Senior Regulatory Affairs Specialist

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Regulatory Affairs Specialist based in United States.

As a Senior Regulatory Affairs Specialist, you will help shape regulatory strategy and operations across a growing Software as a Medical Device (SaMD) portfolio.
You will support products throughout their lifecycle, from development and submissions through launch and post-market activities.
The role combines hands-on regulatory execution, strong documentation discipline, and cross-functional collaboration.
You will work closely with Quality, Engineering, Product, Clinical, and Legal teams to ensure regulatory requirements are translated into practical actions.
Your work will contribute directly to compliant product development, efficient market access, and sustained inspection and audit readiness.
This is an opportunity to join a fast-moving digital health environment where regulatory expertise can have a meaningful impact on innovative health technologies.

• Lead and support regulatory and quality strategies for product development, approvals, launches, and lifecycle management across wellness and regulated product features.
• Support regulatory operations for SaMD products throughout development, submission, launch, and post-market phases.
• Coordinate the preparation, compilation, publishing, submission, and archival of regulatory applications, correspondence, and supporting documentation.
• Maintain accurate regulatory records, including submission trackers, product registrations and listings, regulatory commitments, approval and clearance records, and change assessment logs.
• Support design change assessments and evaluate the potential regulatory impact of software updates, labeling changes, and other product modifications.
• Track and communicate regulatory milestones, approvals, renewals, commitments, and post-market reporting requirements.
• Support UDI, registration, listing, and market-access maintenance activities where applicable.
• Contribute to inspection and audit readiness by organizing regulatory evidence and ensuring documentation remains complete, accurate, and current.
• Monitor evolving regulations, regulatory guidance, and industry standards relevant to SaMD and translate changes into actionable operational requirements.
• Collaborate with Quality, Engineering, Product, Clinical, Legal, and other stakeholders to improve regulatory processes, templates, tools, and workflows.
• Help strengthen scalable regulatory operations and promote efficient, compliant execution across the product lifecycle.

Requirements:

• Bachelor’s degree in a scientific, engineering, healthcare, or related discipline.
• 5+ years of experience in regulatory affairs or regulatory operations within medical devices, digital health, or another regulated healthcare product environment.
• Hands-on experience supporting software-based medical products or Software as a Medical Device (SaMD).
• Working knowledge of key regulatory frameworks and standards, including FDA medical device requirements, EU MDR, ISO 13485, IEC 62304, and ISO 14971.
• Experience compiling, maintaining, and managing regulatory documentation within a controlled environment.
• Strong project coordination, organization, documentation, and deadline-management skills.
• Exceptional attention to detail and a strong commitment to accuracy and compliance.
• Excellent written and verbal communication skills, with the ability to collaborate effectively across technical and non-technical teams.
• Ability to manage multiple priorities in a fast-paced environment while maintaining high-quality work.
• Experience supporting 510(k), De Novo, technical documentation, or international regulatory registrations is preferred.
• Familiarity with eQMS, document control, and regulatory submission management tools is a plus.
• Experience with software change assessments, traceability, and product lifecycle documentation is advantageous.
• Understanding of cybersecurity, labeling, and post-market requirements for SaMD is preferred.
• RAC certification or relevant regulatory training is a plus.
• Experience working within a startup or high-growth medtech environment is desirable.

Benefits:

• Competitive salary and equity packages.
• US market-based compensation determined by location, skills, experience, qualifications, internal equity, and market conditions.
• Region 1: $151,300–$178,000.
• Region 2: $138,550–$163,000.
• Region 3: $127,500–$150,000.
• Health, dental, and vision insurance.
• Mental health and well-being resources.
• Company-provided wearable health device and employee discounts for friends and family.
• 20 days of paid time off.
• 13 paid holidays.
• 8 days of flexible wellness time off.
• Paid sick leave and parental leave.
• Opportunity to work in a fast-growing digital health and medical technology environment.
• Inclusive workplace committed to equal employment opportunities and reasonable accommodations.
• Location eligibility: Candidates residing in Alaska, Delaware, Iowa, Mississippi, Nebraska, South Dakota, West Virginia, or Wisconsin are not currently considered.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

#LI-CL1