1,149 Trade Regulations 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

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

Regulatory Affairs Manager - Biologics

Job Purpose

** MUST HAVE BIOLOGICS EXPERIENCE **

LOCATION: On-site in Lenoir, NC

** Will assist in relocation **

The Americas Regulatory Affairs Manager is responsible for overseeing and managing the routine operations of the regulatory affairs department. In this role, the Manager ensures compliance with applicable regulatory requirements, including those from the US FDA, Health Canada, USDA, and other applicable regulatory agencies, while providing regulatory strategy and support across the business.

Major Accountabilities

• Oversee and manage all Regulatory Affairs activities to ensure the technical accuracy, quality, content and format of all regulatory submissions in the appropriate format (eCTD) to the FDA, Health Canada, USDA, and other regulatory agencies.
• Lead the preparation, submission and management of regulatory filings such as INDs, BLAs, 510(k)s and/or other market authorization applications for both existing and new products.
• Assess and address regulatory impact of product and manufacturing changes, including overseeing change control assessments.
• Plan, coordinate and participate in formal meetings, teleconferences, and written communication with regulatory agencies, ensuring timely responses to requests.
• Oversee the preparation, review, and submission of all biologic and veterinary prescribing information and product labeling, ensuring compliance with all regulatory requirements.
• Review and approve promotional and advertising materials, ensuring adherence to applicable laws, regulations, and company policies, including timely submission of materials to regulatory agencies.
• Provide regulatory strategy guidance to project teams and other departments to support product development and life cycle management.

Professional Experience/Qualifications

• 5+ years of related regulatory experience in the biologics and medical device areas.
• Regulatory Affairs Certification (RAC) is preferred.
• Thorough understanding of the laws and regulations for the US FDA, Health Canada, USDA, ICH Guidelines, and any other applicable Agency.

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.

• Support U.S. and international product compliance, from ingredients and labeling to certifications.
• Help launch new food and nutrition products by prepping regulatory documentation, reviewing packaging/claims, and coordinating with certifying bodies (e.g., Non-GMO, Kosher, Organic).
• Ensure trade compliance through export filings, Certificates of Analysis, and more.
• Monitor evolving global regulations and track how they impact product formulation, labeling, and market access.
• Contribute to SOP development and broader compliance projects—because small improvements ripple big.