57 Pharmaceutical Services jobs in Dallas

Acumed LLC

As a part of the global industrial organization Marmon Holdings-which is backed by Berkshire Hathaway-you'll be doing things that matter, leading at every level, and winning a better way. We're committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone's empowered to be their best.

Job Scope

The Regulatory Affairs (RA) Specialist is responsible for ensuring regulatory compliance for medical devices in accordance with applicable regulatory requirements (FDA, ISO, CE, etc.). The Regulatory Affairs Specialist will assist in regulatory submissions, listings, and registration of medical devices to comply with applicable regulatory standards dependent on functional RA scope (International, RA, Pre-Market and Strategy RA, Post-Market RA, etc.).

With increasing levels, the Regulatory Affairs Specialist will be expected to provide increasing leadership and mentoring along with more cross functional interaction both internally and externally.

Responsibilities

• Understands regulations, follows complex directions, and investigates when clarification is needed.
• Maintains working knowledge of the medical device regulations applicable to the devices being supported including, but not limited to, registration, classification, labeling, and post-market surveillance requirement through on-going education and training.
• Reports relevant regulation and standard changes and assists in determining impact and appropriate action. Ensures regulatory compliance of products and processes through participation in process updates.
• Assists in determination of appropriate safety, regulatory, evaluation and testing requirements for new and approved products.
• Works with team members to conduct documentation reviews and change assessments including evaluation of effects of regulatory, design, and manufacturing changes, and helps determine required regulatory action e.g., submissions, notifications.
• Prepares, organizes, and coordinates data for submission to and manages correspondence with the regulatory and standards agencies or organizations such as but not limited to FDA, Notified Body, Health Canada, ISO, Acumed's EU Authorized Representative, ANVISA, PMDA, TGA, and Third-Party License Holders.
• Manages correspondence with regulatory and standards agencies or organizations such as but not limited to FDA, Notified Body, Health Canada, ISO, Acumed's EU Authorized Representative, ANVISA, PMDA, TGA, and Third-Party License Holders.
• Supports internal and external (third party) audits as required.
• Assists in development, organization, and application of labeling e.g., instructions for use (IFU), package labels, etc. Initiates updates to labeling to ensure compliance with registrations.
• Maintains processes and procedures for essential RA functions.
• Provides regulatory perspective to cross-functional teams e.g., product development and risk management, to ensure products are compliant with relevant US and international medical device standards, codes, and regulations.
• Reviews and disposition ECRs/ECOs for potential impact to new and existing registrations. Converts and/or approves ECRs/ECOs requiring regulatory review.
• Reviews and approves test protocols and test reports necessary to support market registrations.
• Creates and maintains IFUs. Reviews and approves labeling. Provides feedback advertisement/promotional material to ensure regulatory compliance.
• Prepares and ensures content accuracy for Letter to File (LTF) for design changes.
• Prepares and ensures content accuracy for submission to regulatory agencies e.g., 510(k), PMA, vigilance reports, EU MDR Technical Documentation/Design Dossiers, global registration applications, etc.
• Provides regulatory training to lower-level regulatory personnel.
• All other duties as assigned.

• Bachelor's degree in engineering or science discipline.
• 3-5 years of regulatory experience in the medical device industry e.g., quality, regulatory, or engineering. Equivalent industry/educational experience may be considered.
• Thorough working knowledge of applicable FDA, ISO, EU MDR requirements, consensus standards and guidance documents.
• Ability to represent and provide regulatory support in audits/inspections, product development, sustaining activities, and other activities as directed.
• Experience in communications and submissions with regulatory authorities including 510(K)s, product registrations, change notifications, field actions/recalls. etc
• Ability to work well with others.
• Excellent written and verbal communication skills.
• Ability to read and speak English sufficiently to read, understand and complete all documentation.
• Exceptional organizational skills with extensive knowledge of MS Office i.e., Excel, Word, Outlook.
• Knowledge and experience with ERP systems and their applications, SAP preferred.

Acumed LLC

As a part of the global industrial organization Marmon Holdings-which is backed by Berkshire Hathaway-you'll be doing things that matter, leading at every level, and winning a better way. We're committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone's empowered to be their best.

Job Scope

The Regulatory Affairs Specialist 3 develops and executes regulatory strategy and integrates regulatory requirements throughout the product lifecycle. Relies on extensive experience and judgment to plan, create, develop and maintain materials needed for regulatory compliance. Uses technical knowledge to drive new product submissions, listings, and registration of medical devices. Trains and mentors lower-level specialists in regulatory activities.

Responsibilities

• Ensures all processes for the essential functions are documented in procedures.
• Performs internal departmental audits and supports audits by third parties e.g., BSI, FDA and others, as required.
• Initiates and maintains required establishment listings e.g., FDA and EU, including renewal or changes.
• Develops company regulatory strategies and prioritization. Determines the best strategy to register new products in specific global markets.
• Determines appropriate product testing to support registration activities.
• Ensures content accuracy and regulatory compliance for submission to regulatory agencies e.g., 510(k), PMA, MDR Technical Files/Design Dossiers, global registration applications, etc.
• Provides feedback / approval of compliant labeling e.g., IFUs, marketing materials, package labels, etc.
• Manages and leads responses to Regulatory Agency for submission deficiencies.
• Maintains accurate international product registration, including renewal or changes, and certificates for foreign governments.
• Provides direction/guidance as needed to other Regulatory Specialists.

• 5+ years of regulatory experience in medical device industry (equivalent industry/educational experience may be considered)
• Evidence of applied knowledge of applicable FDA, ISO, MDR requirements, consensus standards and guidance documents.
• Ability to work under limited supervision with FDA, Notified Body, EU Authorized Representative, and other global regulatory agencies.
• Able to manage multiple projects simultaneously.
• Proven track record of strong teamwork, creatively strategic thinking.
• Ability to work well with others, support regulatory activities and mentor/train others.
• Excellent written and verbal communication skills.
• Master of Science in Regulatory Affairs preferred.

• This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Requires data analysis, problem solving, and attention to detail.
• Represent RA on project teams by providing regulatory guidance throughout the product development cycle, coordinate team inputs for regulatory submissions, and review and approve applicable design control documentation.
• Support International Product Registrations, including new registrations, re-registrations, and product change registrations/notifications.
• Coordinate and collect specific registration information with R&D, Quality, Medical, Manufacturing, etc.
• Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal "Non-Filing Justifications" (U.S.) for changes that do not require a 510(k) submission.
• Prepare/update technical files for CE marking with appropriate input from various functions (R&D, Quality, Medical, Manufacturing, etc.).
• Submit notifications to the EU Notified Body for significant changes to CE marked products.
• Maintain Regulatory documentation.
• Support special projects, as needed.

• B.S. degree or higher in a life science or technical discipline, preferably in engineering, bioengineering, biology, or chemistry.
• 2-5 years Medical Device experience.
• Working knowledge of industry consensus standards and FDA guidance is required.
• At least 2 years Regulatory Affairs experience in Medical Device regulations.
• Demonstrated success in taking products through FDA and EU Notified Bodies.
• Working knowledge of 510(k), MDD 93/42/EEC.
• Regulatory Affairs Certified RAC (RAPS).
• Proficient in using Microsoft Office.
• Strong communication and project management skills.
• Must be able to handle multiple tasks
• Attention to detail.
• 510(k), MDR.
• 21 CFR 820 - Quality System Regulation, ISO 13485.
• Medical device standards and FDA guidance relevant to medical devices.

Vice President of Regulatory Affairs

About the Company

Prominent AI-powered clean tech company

Industry
Renewables & Environment

Type
Privately Held

About the Role

The Company is in search of a Director or VP of Regulatory Affairs to take on a pivotal role in driving regulatory strategy, influencing policy, and promoting the adoption of advanced grid and customer analytics across North America. The successful candidate will be responsible for leading regulatory engagement with state and regional bodies, advocating for the integration of smart meter analytics in rate cases and grid modernization plans, and supporting utilities in securing funding for innovative energy programs. This high-impact position requires a professional with a strategic mindset for policy, innovation, and market enablement, as well as strong communication and stakeholder engagement skills.

Applicants for this role at the company should have a background in regulatory affairs, particularly within the context of a leading energy software company in the US. Deep experience with utility regulation, including PUCs, GRCs, IRPs, and TEPs, is essential. The role also demands a candidate who can provide thought leadership through various channels, such as conferences, public comments, and industry engagement. The ideal candidate will be a proactive advocate for the company's mission, with a focus on accelerating the adoption of advanced technologies in the energy sector.

Travel Percent
Less than 10%

Functions

• Business Development

• Prepare, review, and submit regulatory filings (e.g., INDs, NDAs, MAAs, variations) to health authorities worldwide.
• Develop and implement regulatory strategies for product development and lifecycle management.
• Interpret and advise on evolving regulatory guidelines and requirements.
• Serve as the primary liaison with regulatory agencies such as the FDA, EMA, and other health authorities.
• Review and approve promotional materials, labeling, and core company documents for regulatory compliance.
• Collaborate with cross-functional teams to ensure regulatory requirements are met throughout the product development process.
• Assess the regulatory implications of product changes and manufacturing processes.
• Maintain regulatory documentation and databases.
• Support regulatory inspections and audits.

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field. Master's or Pharm.D. degree is a plus.
• Minimum of 6 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
• In-depth knowledge of global regulatory guidelines and submission processes (e.g., ICH, FDA, EMA).
• Proven experience in preparing and submitting various types of regulatory applications.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work independently and manage multiple projects simultaneously.
• Strong analytical and problem-solving skills.
• Experience with regulatory information management systems is beneficial.
• Ability to work collaboratively in a hybrid environment.

Who We Are:

Do you have the following skills, experience and drive to succeed in this role Find out below.
Galaxy is a global leader in digital assets and data center infrastructure, delivering solutions that accelerate progress in finance and artificial intelligence. We believe that blockchain and digital asset innovation will transform how value moves through the world and were building the products and services to make that future a reality.

Our institutional digital assets platform spans trading, investment banking, asset management, staking, self-custody, and tokenization technology. We also invest in and operate cutting-edge data center infrastructure to power AI and high-performance computing, addressing the growing demand for scalable energy and compute in the U.S.

We work at the intersection of finance and technology, helping institutions, startups, and developers navigate a digitally native economy. Led by CEO and Founder Michael Novogratz, our team blends deep crypto expertise with institutional experience and a shared commitment to shaping the future of Web3 and AI.

Galaxy is headquartered in New York City, with offices across North America, Europe, the Middle East, and Asia.

To learn more about our businesses and products, visit

What We Value:

We are a diverse team of free thinkers, and fast movers united to help investors and creators energize the global economy. We are looking for individualswhothrive in a culture of builders and overachieversandembrace high performance, transparent feedback, and a mission-first approach. Our culture shapes our way of working and gets us where we want to be.

• Seek Excellence.
• Be Selective To Be Effective.
• Be Highly Aligned, Loosely Coupled.
• Disagree Transparently.
• Encourage Independent Decision-Making.
• Build Dream Teams.

Who You Are:

We are seeking an experienced regulatory affairs and compliance specialist to join the Galaxy Data Centers team where you will assist in ensuring compliance with grid related market rules or statutes for data centers. In addition to ensuring compliance, you will attend Independent System Operator (ISO) or Public Utility Commission (PUC) stakeholder meetings, workshops, and discussions to advocate for Galaxys position within the relevant market. You will also attend trade association meetings, advocating for Galaxys position within those organizations.

You should have at least three years of experience within an ISO or PUC stakeholder environment. You should have experience translating regulatory requirements into planning or operational goals within complex organizations and advocating for reasonable market rules within the market.

You should have the ability to work independently, have strong analytical and problem-solving skills, with a desire to own issues and see them through to resolution.

What Youll Do:

• Become a subject matter expert on the regulatory and compliance requirements for large data center campuses
• Become an expert at advocating for data center positions within a stakeholder setting
• Translate regulatory and compliance mandates from stakeholder settings to internal operational roadmaps

What Were Looking For:

• Experience working within an ISO or PUC stakeholder environment
• Experience advocating for a specific stakeholder class within a political environment or trade organization
• Experience translating regulatory or compliance related requirements into operations or planning requirements

Bonus Points:

• Direct, recent experience within the ERCOT and PUCT stakeholder environment
• Experience advocating for industrial loads or utility scale generation resources within stakeholder environments
• Direct, recent experience working on regulations related to Large Loads

What We Offer:

• Competitive base salary and discretionary bonus
• Paid Time Off
• Company-paid health and protective benefits for employees, partners, and other dependents
• Company Paid Holidays (11)
• 3% 401(k) company contribution
• Generous paid Parental Leave
• Free virtual coaching and counseling sessions through Headspace
• Opportunities to learn about the Crypto industry
• Free daily snacks and weekly meal in-office
• Smart, entrepreneurial, and fun colleagues
• Employee Resource Groups

Apply now and join us on our mission to engineer a new economic paradigm.

Galaxy respects diversity and seeks to provide equal employment opportunities to all employees and job applicants for employment without regard to actual or perceived age, race, color, creed, religion, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, marital or partnership or caregiver status, ancestry, national origin, citizenship status, disability, military or veteran status, protected medical condition as defined by applicable state or local law, genetic information or predisposing genetic characteristic, or other characteristic protected by applicable federal, state, or local laws and ordinances.

We will endeavor to make a reasonable accommodation to the known limitations of a qualified applicant with a disability unless the accommodation would impose an undue hardship on the operation of our business. If you believe you require such assistance to complete the application process or to participate in an interview, please contact