1,468 Regulatory Affairs jobs in the United States

Be part of a mission-driven team focused on improving the lives of patients worldwide. In this Regulatory Specialist role, you’ll play a critical part in bringing transformative orthopedic technologies to market, helping surgeons deliver better outcomes, faster recovery times, and higher quality of life for those with musculoskeletal conditions.

Why You Should Apply

• Join a company that thrives on innovation and real-world patient impact
• Collaborate with cross-functional experts in a fast-paced, clinical product environment
• Play a hands-on role in FDA submissions for breakthrough Class II and III medical devices
• Enjoy a culture that blends urgency, teamwork, and a passion for clinical results

What You’ll Be Doing

• Drafting and submitting 510(k), IDE, and PMA regulatory submissions
• Partnering with Product Development teams to align on regulatory strategy
• Reviewing clinical data and collaborating with internal teams to support submissions
• Maintaining PMA records, preparing supplements and annual reports
• Training team members and contributing to SOP development and regulatory compliance

About You

• Be able to do the job as described
• Bachelor’s in health/science-related field; Engineering degree is a plus
• 2-5 years’ experience in Regulatory Affairs in the medical device industry
• Knowledge of orthopedic medical devices is highly preferred
• Comfortable with FDA regulatory pathways and submission types (Pre-Sub, 510(k), IDE, PMA)
• Strong documentation, review, and cross-functional communication skills

Overview:

A growing biopharmaceutical company is seeking a Regulatory Affairs Manager to lead strategic regulatory operations across the U.S., Canada, and other global markets. This is a high-impact leadership role responsible for overseeing regulatory submissions, compliance, and strategy for biologics and medical devices.

Key Responsibilities:

• Lead preparation and submission of regulatory filings (INDs, BLAs, 510(k)s, etc.) in eCTD format
• Manage communications with regulatory agencies including FDA, Health Canada, and USDA
• Oversee promotional and advertising material review and submission
• Provide regulatory guidance on product development and lifecycle management
• Collaborate cross-functionally with Quality, R&D, Manufacturing, and Commercial teams
• Monitor regulatory changes and ensure ongoing compliance
• Lead and mentor the regulatory team, driving performance and professional growth
• Support budgeting and resource planning for the regulatory department

Qualifications:

• 5+ years of regulatory affairs experience in biologics and/or medical devices
• Strong knowledge of FDA, Health Canada, USDA regulations
• Experience with eCTD submissions and promotional review
• Proven leadership and team management experience
• RAC certification preferred
• Bachelor's degree in a scientific discipline required

Why Apply?

This is an opportunity to make a direct impact on regulatory strategy and product success within a mission-driven organization focused on improving patient outcomes through innovative immunotherapy solutions.

Job title: PRC Submission Management Lead

Location: Foster City, CA

Duration: 06+ Months

Client is seeking a seasoned PRC Submission Management Lead to support the CPC team. This specialized role requires deep expertise in the Medical, Legal, and Regulatory (MLR) review and approval process, with a strong operational focus. The ideal candidate will have hands-on experience managing digital submissions in Veeva Vault and be comfortable navigating the complexities of PRC workflows.

Key Responsibilities

• Serve as a Subject Matter Expert (SME) in US CPC team, ensuring compliance with regulatory standards and internal processes.

• Manage end-to-end MLR review cycles, including submission preparation, routing, and tracking through Veeva Vault.

• Attend PRC meetings to represent submission status, clarify content, and capture feedback.

• Triaging and managing review comments from MLR teams, including coordinating re-review cycles and working closely with agencies or the Content Production Center (CPC) to ensure timely closure.

• Conduct reference checks prior to PRC submission/routing to ensure accuracy and completeness.

• Provide training and guidance to CPC team members on regulatory guidelines and best practices.

• Develop a playbook outlining optimal ways of working across PRC and CPC teams.

• Collaborate with Gilead’s AI team to advise on considerations for developing AI agents that support marketing content creation and regulatory fact-checking.

Qualifications

• Proven experience in US Commercial Regulatory Affairs, specifically within PRC/MLR review operations.

• Strong working knowledge of Veeva Vault, including digital asset submission, routing, and tracking.

• Demonstrated ability to manage complex review cycles and collaborate across cross-functional teams.

• Experience working with agencies and internal content teams to resolve feedback and ensure compliance.

• Operational mindset with the ability to streamline processes, identify gaps, and implement best practices.

• Prior experience in training and documentation development is a plus.

• Familiarity with AI applications in regulatory or marketing contexts is a bonus.

Required Years of Experience: 6-8 years

Top 3 Required Skill Sets:

a. Experience in Medical, Legal, and Regulatory (MLR) review process

b. Proficiency in Veeva Vault PromoMats

c. Project Management and workflow optimization

Top 3 Nice to Have Skill Sets:

a. Documentation and process mindset

b. Change Management

c. Familiarity with AI

Are you looking to start or advance your career in regulatory affairs?

At Scendea, we deliver market-leading scientific expertise and regulatory solutions to advance healthcare innovation worldwide. We are dedicated to streamlining medicinal product development, reducing time-to-market, and minimising costs for our biotech and pharmaceutical clients. If you would like to begin or advance your career in regulatory affairs, and passionate about providing strategic and technical solutions to complex product development challenges, we’d love to hear from you.

What’s involved?

You will play a critical role in providing regulatory guidance and innovative strategies across a wide range of medicinal product development activities.

This exciting opportunity is ideal for someone wanting to start or develop a career in regulatory project management, regulatory affairs and medical/scientific writing. Successful candidates will have a strong interest in facilitating the entry of Client’s compounds into clinical trials and assisting in the activities required for successful international marketing approvals.

At Scendea, we provide the training and guidance to enable you to project manage the delivery of high-quality technical regulatory advice and product development strategies. You will be part of a highly professional, internationally recognised team, with opportunities for career progression within our rapidly growing Regulatory Consultancy.

This includes:

• Project management to ensure delivery of contracted activities, which will include direct contact with multiple clients and stakeholders.
• Complete relevant tasks within scope or under supervision to ensure successful project delivery with adherence to timelines and budgets.
• Support in the creation and delivery of high-quality billable related product development and regulatory-related documentation for clients.
• Develop and maintain technical knowledge in the area of product development and international regulatory affairs.
• Perform literature and data searches, collating and summarising data in an appropriate manner for stakeholders.
• Manage project documentation within company systems.
• Support and develop strategic drug development strategies in the area of regulatory affairs, Non-Clinical, Clinical, and CMC development.
• Assess and analyse scientific data.

What we are looking for:

• A high scientific calibre with a life science focused BSc (or equivalent), and a higher degree (e.g., a life science focused MSc or PhD).
• A general awareness of drug development and medical/regulatory affairs is required, and prior industry experience would be advantageous.
• Any experience with regards to medical/scientific writing would be a strong asset for this position.
• Excellent writing skills in English – you will be expected to summarise complex scientific data, thus facilitating the review of such data by external parties.
• High level of verbal communication and presentation skills in English, computer literacy, and competency in MS Office programs.
• Exemplary organisational and time management skills with a high level of attention to detail, ability to balance competing priorities, and to complete work within a set timeframe.
• Proven ability to work proactively, autonomously, and as part of a team.
• Some experience in project management would be a significant advantage for this role. This could include managing a research project (e.g., during a PhD).
• Willingness to work flexible hours and travel for short periods, sometimes at short notice, within the US, and or internationally.
• A clear ambition to progress your career in medical/scientific writing and regulatory consulting.
• Commercial experience is not a prerequisite for this position.

Why Scendea?

Scendea is an international product development and regulatory consulting group delivering market-leading scientific expertise & regulatory solutions, to advance healthcare innovation worldwide. We are passionate about delivering strategic and operational support to clients, with a strong commitment to problem-solving and redefining customer service.

With a current team of over 50 staff based in the UK, Netherlands, Australia, and the US, Scendea is undergoing a period of significant growth, with the addition of new office locations and service lines to facilitate the delivery of expert and strategic global regulatory consulting services to our rapidly growing client base. We are equally committed to making a positive impact on society by managing our environmental impacts and contributing to a low-carbon economy. Our inclusive work culture values transparency, ethical collaboration with clients, and employee involvement in key decision-making processes, ensuring that our team is respected, supported, and engaged.

As a Scendea Employee

Part of what makes Scendea successful is the highly motivated people who work for us and their enthusiasm for what we do and stand for. We recruit individuals whose passion, drive, integrity and customer orientation shines through. You are a motivated individual who can instil trust and confidence in our customer relationships whilst having a natural aptitude for getting the best out of people internally. You will inspire others through your commitment, motivation, expertise, professional manner and always placing the customer at the centre of everything you do.

You will also receive;

• A competitive salary.
• Generous bonus program, which rewards success.
• Holiday plus public holidays, and discretionary additional days for birthday and work anniversary.
• Employer pension contribution.
• Provision of Private healthcare insurance.
• Access to Employee Assistance Programme.
• Employee Ownership Trust Scheme.
• A challenging and stimulating position for a dynamic and competent scientist, looking to contribute to a growing business and a rapidly expanding team.
• Coaching, mentoring and support of your continuous learning, and professional development within a highly recognised international team.

Register your interest today!

We are always looking for talented individuals to join our global team. If this sounds like the next step in your career, click “Apply” to register your interest.

Regualtory Affairs Product Manager - PMA Submissions

Overview:

Our client is seeking a Regulatory Affairs Product Manager to support Class III medical device product life-cycle activities at their site outside of Atlanta, Georgia. This role is responsible for ensuring timely delivery of regulatory tasks, maintaining compliance with internal procedures and external regulations, and providing cross-functional support to internal stakeholders.

Key Responsibilities:

• Support preparation and submission of US FDA PMA submissions
• Support maintenance of Canadian product licenses
• Assess product and process changes and perform regulatory impact assessments
• Prepare and maintain PMA-related documentation and other regulatory deliverables
• Provide regulatory support to project core teams, as assigned
• Manage international registrations and renewals, as needed
• Perform regulatory listings for approved products to ensure appropriate shipping controls
• Deliver regulatory support to meet internal customer and business needs, as assigned

About Us

Intersurgical Inc. is a global leader in the fields of anesthesia, respiratory care and medical device manufacturing. We partner with providers, manufacturers and other organizations to supply innovative airway and medical devices that impact the lives of patients every day. Driven by our commitment to supply high quality medical devices, our team works to deliver best in class products to over 60 countries worldwide.

Our Culture

We celebrate our culture of collaboration and communication. We believe in a workplace where everyone can be their full, authentic selves. We welcome and encourage those with diverse perspectives, veterans, and individuals with disabilities to join our team. We are an ambitious and innovative company and look forward to the unique experiences and different points of view you'll bring to the table while fostering a spirit of communication.

Job Overview

Primary responsibility is assisting with activities pertaining to the submissions and communications with regulatory authorities such as Food and Drug Administration and other local or regional bodies. Assist with generating, coordinating and maintaining documentation required to allow products to be marketed in the USA.

Key Responsibilities

• Support the assessment activities for determining the regulatory path for new devices
• Support preparation, documentation and submission activities for regulatory submissions for US market
• Prepare the documentation for justification when no submission is required for regulatory clearance.
• Maintain regulatory compliance records for devices
• Assist with maintaining current regulatory status for devices on the market
• Participate in the assessment of device changes for regulatory implications
• Prepare reports and documents to support regulatory submissions for changes when required
• Assist in ensuring product labeling, advertising, and promotional materials comply with FDA regulations
• Provide back-up support for other roles, as necessary. Other duties as assigned by the manager/supervisor

Qualifications & Skills

• Bachelor's degree in related field, or experience in related field
• 5 years experience with medical device FDA 510k submissions
• Communication and leadership skills
• Ability to see the big picture while focusing on the process and procedures necessary to produce deliverables
• Ability to work independently and collaboratively
• Knowledge of medical device and quality systems

Requirements

• Must be able to speak, read, and write English fluently

Work Environment

• Sit at computer for long periods
• May occasionally be required to sit, stoop, bend, reach, and lift items up to 50 pounds
• Office setting, possible remote work, infrequent travel

We are an Equal Opportunity Employer that takes pride in a diverse environment. We do not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, gender, sexual orientation, national origin, age, marital or veteran status, medical condition or disability, or any other legally protected status.

Benefits

We are passionate about the well-being of others and that begins with caring for our people.

• ️ 1 Work From Home Day/Week
• Competitive pay