5,455 Regulatory Standards jobs in the United States

About the Job

The VP, Regulatory Affairs and Quality Assurance will be a key strategic member of the senior leadership team, responsible for overall management of Regulatory and Quality activities in support of Foundation Medicines growth objectives. In addition to their externally-facing activities, they will play an important role collaborating cross-functionally with Global Laboratory Operations, Product Development, Marketing, Manufacturing, Legal and certain strategic outside partners. The head of RA/QA will be a key leader in enhancing and developing the organizations RA/QA capabilities and qualifications to enable strategic initiatives.

Key Responsibilities

• Development, implementation, maintenance and overall success of the companys regulatory affairs and quality assurance strategy & programs; including establishing quality standards/metrics/objectives, developing methods to embed quality into the product development and manufacturing process, establishing supplier relationships and quality standards and developing and implementing innovative programs to focus employees on improving product quality.
• Building and managing relationships with FDA and global regulatory agencies and standards groups.
• Defining and implementing regulatory strategies and submissions in support of new and existing products as relevant.
• Developing and maintaining current regulatory knowledge and staying abreast of regulatory procedures and changes, interpreting regulations, providing regulatory insight, advice and support to other functions.
• Leads internal and external quality audits and preparation of audit reports, corrective action plans and follow up updates.
• Ensure adequacy of departmental and company standard operating procedures (SOPs) from a GxP perspective.
• Oversee global regulatory strategy and submissions in compliance with all applicable global regulatory requirements and in alignment with corporate goals.
• Serve as the company representative for the FDA and other relevant external stakeholders, including Twist Biopharmaceutical partnerships.
• Ensure supplier quality objectives are met.
• Provide strategic and technical leadership of Quality Assurance activities and deliverables in support of the product pipelines.
• Collaborate with senior management and all functional groups at all levels of the enterprise to drive a culture of Quality.
• Implement, monitor, and promote best practices of Quality Management Systems to ensure compliance with relevant FDA, EU, and global regulations/directives/requirements.
• Identify, resolve, or escalate any and all product, process or customer Quality-related issues that pose risk with respect to the patient, customers or compliance.
• Develop and manage department and study-specific budgets.
• Will be part of a Global Leadership Team and will need to collaborate effectively on broader initiatives.

Qualifications:

Basic Qualifications:

• Bachelors degree in relevant area of engineering or scientific discipline. Advanced degree (MS or PhD) is strongly preferred.
• Demonstrated and proven experience within their area of work and 15+ years of equivalent combined regulatory and quality professional experience.
• 10+ years of leadership experience of cross functional teams.

Preferred Qualifications:

• Advanced Degree in Law, Health Policy, Regulatory Affairs or Science
• Experience with in vitro diagnostics, laboratory-developed tests, diagnostics medical device products, and/or therapeutics development including hands-on experience in developing and implementing policies and procedures for Regulatory Affairs and Quality
• The VP RA/QA will be analytical, results and process oriented by nature, detail driven, possesses strong interpersonal skills, and have a desire and passion for quality and regulatory compliance.
• Excellent working knowledge of the US and global regulatory framework and their relevant governing authorities with direct experience handling submissions (e.g., PMA, 510(k), CE Marking).
• Direct experience with FDA Quality System Regulations and ISO 13485 regulatory requirements and implementation.
• 5+ years experience in Regulatory and Quality strategy development
• 5+ years experience in companion diagnostic work
• Extensive experience in preparing and leading engagements directly with regulatory agencies. Ability to coach others to do the same.
• A commercial focus in the application of regulatory requirements.
• Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving.
• Strong conceptual, analytical, and problem-solving abilities.
• Excellent time management and organizational skills and demonstrated ability to manage and prioritize multiple teams, multiple projects, and meet deadlines.
• Understanding of HIPPA and importance of patient data privacy
• Ability to travel based on business needs, typically 10-20%, but flexing higher when needed.
• Commitment to reflect FMIs values: passion, patients, innovation, and collaboration.

#LI-Onsite

• Development, implementation, maintenance and overall success of the company's regulatory affairs and quality assurance strategy & programs; including establishing quality standards/metrics/objectives, developing methods to embed quality into the product development and manufacturing process, establishing supplier relationships and quality standards and developing and implementing innovative programs to focus employees on improving product quality.
• Building and managing relationships with FDA and global regulatory agencies and standards groups.
• Defining and implementing regulatory strategies and submissions in support of new and existing products as relevant.
• Developing and maintaining current regulatory knowledge and staying abreast of regulatory procedures and changes, interpreting regulations, providing regulatory insight, advice and support to other functions.
• Leads internal and external quality audits and preparation of audit reports, corrective action plans and follow up updates.
• Ensure adequacy of departmental and company standard operating procedures (SOPs) from a GxP perspective.
• Oversee global regulatory strategy and submissions in compliance with all applicable global regulatory requirements and in alignment with corporate goals.
• Serve as the company representative for the FDA and other relevant external stakeholders, including Twist Biopharmaceutical partnerships.
• Ensure supplier quality objectives are met.
• Provide strategic and technical leadership of Quality Assurance activities and deliverables in support of the product pipelines.
• Collaborate with senior management and all functional groups at all levels of the enterprise to drive a culture of Quality.
• Implement, monitor, and promote best practices of Quality Management Systems to ensure compliance with relevant FDA, EU, and global regulations/directives/requirements.
• Identify, resolve, or escalate any and all product, process or customer Quality-related issues that pose risk with respect to the patient, customers or compliance.
• Develop and manage department and study-specific budgets.
• Will be part of a Global Leadership Team and will need to collaborate effectively on broader initiatives.

• Bachelor's degree in relevant area of engineering or scientific discipline. Advanced degree (MS or PhD) is strongly preferred.
• Demonstrated and proven experience within their area of work and 15+ years of equivalent combined regulatory and quality professional experience.
• 10+ years of leadership experience of cross functional teams.

• Advanced Degree in Law, Health Policy, Regulatory Affairs or Science
• Experience with in vitro diagnostics, laboratory-developed tests, diagnostics medical device products, and/or therapeutics development including hands-on experience in developing and implementing policies and procedures for Regulatory Affairs and Quality
• The VP RA/QA will be analytical, results and process oriented by nature, detail driven, possesses strong interpersonal skills, and have a desire and passion for quality and regulatory compliance.
• Excellent working knowledge of the US and global regulatory framework and their relevant governing authorities with direct experience handling submissions (e.g., PMA, 510(k), CE Marking).
• Direct experience with FDA Quality System Regulations and ISO 13485 regulatory requirements and implementation.
• 5+ years' experience in Regulatory and Quality strategy development
• 5+ years' experience in companion diagnostic work
• Extensive experience in preparing and leading engagements directly with regulatory agencies. Ability to coach others to do the same.
• A commercial focus in the application of regulatory requirements.
• Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving.
• Strong conceptual, analytical, and problem-solving abilities.
• Excellent time management and organizational skills and demonstrated ability to manage and prioritize multiple teams, multiple projects, and meet deadlines.
• Understanding of HIPPA and importance of patient data privacy
• Ability to travel based on business needs, typically 10-20%, but flexing higher when needed.
• Commitment to reflect FMI's values: passion, patients, innovation, and collaboration.

Quality Assurance & Regulatory Affairs Specialist (Personal Care)

Manufacturing

Los Angeles , CA, US

Pay Rate Low: 35 | Pay Rate High: 42

• Added - 11/07/2025

Apply for Job

QA/RA Specialist (Personal Care)

Employment Type: 6-month contract to hire

Location: Los Angeles, CA - State-of-the-art new facility

Schedule: Monday through Friday, 8:00 AM - 5:00 PM

Compensation: $35-42/hour (negotiable for exceptional candidates)

Start Date: Immediate availability preferred

About This Opportunity

Join a rapidly expanding organization in the innovative anti-aging skincare industry. Our flagship product line is experiencing significant market growth, and we're seeking a dedicated professional to support our regulatory compliance initiatives as we expand our over-the-counter product portfolio, including sun protection formulations.

Key Responsibilities

Daily activities will include:

• Supporting comprehensive internal and external audit processes.

• Overseeing regulatory documentation systems and version control.

• Providing expert consultation on product labeling and packaging compliance.

• Investigating and resolving customer feedback and complaint management.

• Conducting root cause analysis for quality-related issues.

• Managing product packaging specifications and labeling requirements.

Essential Requirements:

• Comprehensive knowledge of OTC regulatory compliance frameworks.

• Hands-on experience with personal care products (sunscreens, moisturizers, topical treatments).

• Adaptability and willingness to take on diverse responsibilities in a dynamic environment.

• Bachelor's degree preferred.

• Minimum 3 years of relevant regulatory experience.

• Proficiency in Microsoft Office Suite.

• Demonstrated experience with OTC product registration processes

Working Environment: This is a fast-paced startup environment where self-directed professionals thrive. We're looking for someone who can contribute immediately without extensive onboarding.

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

INDBH

#LI-DNP

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Product Quality Assurance and Regulatory Affairs Senior Specialist Join to apply for the Product Quality Assurance and Regulatory Affairs Senior Specialist role at Best Buy Product Quality Assurance and Regulatory Affairs Senior Specialist 1 day ago Be among the first 25 applicants Join to apply for the Product Quality Assurance and Regulatory Affairs Senior Specialist role at Best Buy As a Product Quality Assurance and Regulatory Affairs Senior Specialist, you are responsible for supporting the safety and compliance of products sold on our Marketplace. You’ll be involved in reviewing products and safety incidents, monitoring compliance with local, state, and federal regulations, and collaborating with internal teams, sellers, and regulatory bodies. This role is hybrid, which means you will work some days at a Best Buy location and some days virtually from home or another non-Best Buy location. The specific work arrangements vary by role and team. The recruiter or hiring manager will provide more details during the hiring process. What You’ll Do Maximize AI capabilities that regularly audit items added to Marketplace while identifying high-risk products needing further review. Research and stay up to date on regulatory changes, including new laws, amendments, and compliance guidelines affecting product assortment (packaging, labeling, and sales restrictions). Conduct detailed safety assessments of high-risk products, including reviewing specifications, manufacturer age recommendations, compliance documents, product claims and marketing, and mystery shopping to identify potential non-compliance to recommend any necessary corrective actions. Investigate and manage incidents related to customer product safety reports, coordinate root cause analyses, and ensure timely resolutions. Partner with Government Affairs, Environmental Compliance, and other cross-functional teams to ensure products meet safety standards, environmental regulations, hazmat shipping, and certification requirements. Participate in assortment development meetings to provide compliance input during the onboarding phase. Basic Qualifications Minimum of 2+ years of experience in product compliance/safety, regulatory compliance, government affairs, incident management, data analysis, or customer service, preferably in retail, e-commerce, or Marketplace. Basic knowledge of product safety and compliance regulations, such as safety standards, labeling regulations, or environmental laws (e.g., PFAS, Prop 65, UL marking, FDA). Excellent analytical skills, a curious mindset, and the ability to interpret and apply regulatory requirements. Strong communication skills and ability to translate complex regulatory language into actionable insights for non-technical stakeholders. Intermediate proficiency with Microsoft Office Suite. Preferred qualifications Basic understanding of product safety regulations, standards, and certifications (e.g., ASTM, IEC, ISO, CPSC) and familiarity with industry-specific regulations. Specific training or certifications in product safety, quality, or risk management. Experience with regulatory agencies, quality assurance, testing labs, or compliance documentation. Experience in creating and using AI tools to manage high volumes of data. Experience with customer incident reporting and analysis. What’s In It For You We’re committed to helping our people thrive at work and at home. We offer generous benefits that address your total well-being and provide support as you need it, especially key moments in your life. Our Benefits Include Competitive pay Generous employee discount Physical and mental well-being support About Us As part of the Best Buy team, you’ll help us fulfill our purpose to enrich lives through technology. We bring that to life every day by humanizing and personalizing tech solutions for every stage of life — in our stores, online and in customers’ homes. Our culture is built on deeply supporting and valuing our amazing employees who make it all possible. We’re committed to being a great place to work, where you can unlock unique career possibilities. Above all, we aim to provide a place where you can bring your full, authentic self to work now and into the future. Tomorrow works here. Best Buy is an equal opportunity employer. Position Type: Full timePandoLogic. Keywords: Product Marketing Specialist, Location: Minneapolis, MN - 55423 Seniority level Seniority level Not Applicable Employment type Employment type Full-time Job function Job function Sales and Business Development Industries Retail Referrals increase your chances of interviewing at Best Buy by 2x Sign in to set job alerts for “Product Specialist” roles. 100% WFH Account Executive - Promotional Products Maplewood, MN $160,284.00-$95,903.00 2 weeks ago Minneapolis, MN 65,000.00- 85,000.00 4 days ago Apple Valley, MN 85,000.00- 104,000.00 1 month ago Senior Principal, Supply Chain Product Specialist Minneapolis, MN 75,000.00- 85,000.00 1 week ago Minneapolis, MN 65,000.00- 85,000.00 2 weeks ago National Customer Experience Representative St Louis Park, MN 76,000.00- 141,100.00 2 weeks ago Sales Analyst - Business Aviation - Minneapolis Business Analyst for Business Side PBM Project Sourcing Manager – Aluminum Extrusions, Castings, Steel Products Minneapolis, MN $6 ,000.00- 142,000.00 1 month ago National Customer Experience Representative business Data Analyst - Pricing & Reporting Anoka, MN 76,000.00- 141,100.00 2 weeks ago Business Analyst – Process Industrial Engineer (ATS) Business Analyst – Process Industrial Engineer (AAH) Eagan, MN $116 900.00- 217,100.00 2 weeks ago Bloomington, MN 70,000.00- 80,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

Sr. Program Manager, Quality Assurance/Regulatory Affairs Join to apply for the Sr. Program Manager, Quality Assurance/Regulatory Affairs role at Quest Diagnostics Sr. Program Manager, Quality Assurance/Regulatory Affairs Join to apply for the Sr. Program Manager, Quality Assurance/Regulatory Affairs role at Quest Diagnostics Get AI-powered advice on this job and more exclusive features. The Sr. Program Manager, Quality Assurance/Regulatory Affairs will lead a variety of large projects or programs within the Quality & Regulatory Affairs organization with special focus on deployment of an enterprise-wide electronic Quality Management System (eQMS). This position will be responsible for overseeing the planning, execution, integration, and optimization of the eQMS technology across Quest Diagnostics’ business units, laboratories, ensuring alignment with regulatory requirements (FDA, CAP, CLIA, ISO etc.) industry best practices, and internal quality objectives This is a hybrid role, and the Sr. Program Manager will work from a major Quest Diagnostics site 3 days per week. Sites may include Marlborough, MA, Pittsburgh, PA, Baltimore, MD, Tucker, GA, Miami, FL, Wood Dale, IL, Lenexa, KS, Houston, TX, Dallas, TX, etc. Responsibilities Leads end to end implementation of e-QMS technology across multiple functional areas including Document Control, CAPA, Change Control, Audit Management, Training, and Complaint Management. Leads projects and working teams to effectively initiate, plan, execute, monitor, and close projects with close collaboration with IT, Quality, Regulatory Affairs, and Operations teams. Leads projects Leads projects through issues, roadblocks, and problems Acts as a change agent to drive teams toward success Guides team members to perform through issues and constraints Owns the timeline, budget, resource constraints, and deliverables/results Shifts between the big picture and the small-but-crucial details Is prepared to roll up their sleeves and work through detailed issues Ensures all appropriate tools are completed and used effectively (e.g., charter, Gantt chart, status updates) Communicates Actively communicates with project sponsors and stakeholders Establishes regular points of communication Manages sponsor and stakeholders expectations. Delivers the expected results Performs root cause analysis on project shortfalls and takes corrective action as necessary Serve as a liaison between internal stakeholders, and external vendors/partners to ensure smooth system integration and configuration. Facilitate user requirements gathering, system design specifications, validation planning, and change management strategies. Leads or coordinates validation activities for business deliverables such as data migration verification, PQ, or UAT Ensure the eQMS is implemented in compliance with applicable regulations (21 CFR Part 11, ISO 13485, GxP) and partners closely with Quality Systems to ensure Quality management system readiness and adoption of new processes Lead training, communication, and organizational readiness efforts to support successful adoption and sustained use of the system Applies project management tools and techniques toward a variety of large, and likely inter-related, projects Establishes and leads programs comprised of multiple projects, including designing how information is rolled up and cascaded down, operating rhythms and mechanisms, and tracking against the integrated set of milestones and deliverables Participates in Communities of Practice Documents business processes Qualifications Required Work Experience: Demonstrated experience leading large or complex projects with multiple workstreams from initiation to completion within a regulated healthcare, diagnostics, medical device, or pharmaceutical environment (7-10 years experience) Knowledge: Direct experience leading eQMS implementations (e.g. Veeva, MasterControl, TrackWise, ETQ, ComplianceQuest) Demonstrated knowledge of FDA, ISO, GxP and other relevant quality and regulatory standards Strong experience with computer system validation (CSV) and Part 11 compliance Demonstrated experience facilitating discussions or workshops Demonstrated ability to develop strong relationships with others Demonstrated experience leading changes Demonstrated ability to influence business leaders Some experience with process management Basic knowledge of VOC tools General knowledge of Hoshin and breakthrough planning Skills: Demonstrated data analysis skills Effective written and verbal communication skills across multiple formats: formal presentations, meetings, conference calls, e-mails, and memos Skilled in Microsoft Word, Excel, PowerPoint, and Project Interpersonal skills Planning and organization skills Results-oriented Creative Persistent Composed Able to learn new concepts rapidly Able to work independently with little supervision Education Bachelor’s Degree (Required) Licenses/Certifications Formal training in project management or continuous improvement methodologies (e.g., Six Sigma, Total Quality Management, Lean, Theory of Constraints) PMI Project Management Professional (PMP) (Strongly Preferred) Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Quality Assurance and Other Industries Medical and Diagnostic Laboratories and Hospitals and Health Care Referrals increase your chances of interviewing at Quest Diagnostics by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Disability insurance Tuition assistance Get notified when a new job is posted. Sign in to set job alerts for “Program Manager” roles. Program Manager, Operations and Deployment Dallas, TX $150,000.00-$90,000.00 4 weeks ago People Project & Program Manager, People Services & Support Plano, TX 96,000.00- 143,000.00 2 weeks ago Dallas-Fort Worth Metroplex 115,000.00- 140,000.00 3 weeks ago Program Manager - DEA Foreign and Language Training Program Plano, TX 135,000.00- 150,000.00 7 months ago Dallas, TX 50,000.00- 55,000.00 3 weeks ago Dallas, TX 100,000.00- 120,000.00 2 weeks ago Dallas, TX 50,100.00- 107,200.00 2 weeks ago Plano, TX 100,000.00- 125,000.00 1 month ago Dallas-Fort Worth Metroplex 150,000.00- 180,000.00 2 weeks ago People Planning & Initiatives Program Manager We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

Titan Decking LLC is a leading manufacturer and supplier of high-performance marine decking solutions for boats, docks, and waterfront structures. With a commitment to durability, safety, and innovation, we pride ourselves on delivering premium products that stand up to the harshest marine environments. We are currently seeking a detail-oriented and proactive Quality Assurance Representative to join our growing team.

As a Quality Assurance Representative , you will play a vital role in maintaining the high standards of quality our customers expect. You will oversee product inspections, analyze manufacturing processes, identify potential issues, and collaborate across departments to ensure compliance with company specifications, industry standards, and customer expectations.

Key Responsibilities:

• Conduct inspections of incoming materials, in-process production, and final products.

• Document quality issues, test results, and corrective actions accurately.

• Collaborate with production, engineering, and shipping teams to resolve quality-related concerns.

• Maintain and update quality control documentation and checklists.

• Assist in the development and implementation of QA processes and procedures.

• Ensure compliance with NAVSEA standards and marine safety regulations.

• Participate in internal audits and customer inspections when necessary.

• Train team members on quality standards and proper inspection techniques.

• Recommend improvements to enhance product quality and operational efficiency.

Qualifications:

• High school diploma or GED required; Associate’s or Bachelor’s degree preferred.

• 2+ years of quality assurance or inspection experience in manufacturing (marine industry a plus).

• Strong understanding of QA methodologies, inspection tools, and testing procedures.

• Familiarity with composite materials, adhesives, and marine-grade components is an advantage.

• Excellent attention to detail, organizational skills, and problem-solving abilities.

• Ability to read and interpret technical drawings and product specifications.

• Proficient with Microsoft Office and QA software (experience with Dynamic systems a plus).

• Strong communication skills, both written and verbal.

• Direct Hire Opportunity!
• Meaningful Work!
• Best in Class Company!
• Competitive Compensation Package!
• Complete Benefits Package!
• Accelerated Career Growth!
• Fun Company Activities!
• Many More!

Job Description Job Description Diversified Sourcing Solutions is looking to add to our growing team in Montgomery, AL. This role is for a quality assurance technician on 2nd shift (3pm-11pm) starting at 23.07 per our depending on experience. The main duties for this position are to ensure customer parts meet the organizations and customers product integrity requirements. Duties/Responsibilities: Manage containment of parts and provide daily information for containment and cost status. Conduct initial investigation for all Quality concerns. Conduct analysis, root cause the issue and provide corrective actions to ensure the customer is not affected. Work together with relevant teams and departments to improve Quality issues. Ensure products adhere to company and industry quality standards. Preferred Skills/Abilities: Understanding of how to read 2D and electrical schematics drawings. Ability to read and interpret blueprints, diagrams, and sketches. Excellent verbal and written communication skills. Excellent organizational skills and attention to detail. Strong analytical and problem-solving skills. Proficient with Microsoft Office Suite or related software. Education and Experience: Bachelor's degree and/or electrical/mechanical experience preferred. Three years of related experience required. Company Description Connecting Companies with Good Employees, and Employees with Good Companies Company Description Connecting Companies with Good Employees, and Employees with Good Companies