Regulatory Affairs Principal

Jobgether

About The Position

This role offers a high-impact opportunity to lead regulatory strategy and ensure compliance across new product development and modifications. You will serve as the departmentâs expert on regulatory submissions, product labeling, and quality standards, guiding internal teams through complex regulatory frameworks. Your work will directly influence product approvals, supporting domestic and global commercialization while maintaining alignment with FDA, EU, ISO, and other regulatory requirements. The position requires both strategic oversight and hands-on involvement in documentation, submission preparation, and post-clearance activities. You will collaborate with cross-functional teams, mentor colleagues, and contribute to continuous improvement in regulatory processes. The ideal candidate thrives in a detail-oriented, standards-driven environment, balancing precision with proactive problem-solving.

Requirements

Bachelor of Science in Biology, Biochemistry, Microbiology, Regulatory Affairs, or related field
Minimum 7 years of experience in the medical devices industry, including regulatory compliance, product design, development, and manufacturing regulations (21 CFR Part 820, IVD Directive 98/79 EC, ISO 13485)
At least 7 yearsâ experience supporting medical device regulatory submissions (510(k)s, PMAs)
Professional certification (RAC/ASQ) required
Proven success obtaining FDA and other regulatory agency approvals and clearances
Strong knowledge of FDA regulations, In Vitro Device Directive, MDSAP, ISO standards, and international regulatory requirements
Demonstrated ability to work independently, identify issues proactively, and resolve quality discrepancies collaboratively
Proficiency with Microsoft Word, Excel, and database management; familiarity with inspection tools and statistical analysis

Nice To Haves

Experience with global regulatory submissions and compliance strategies
Knowledge of emerging regulatory trends and the ability to implement process improvements
Strong mentorship and training experience in regulatory affairs

Responsibilities

Lead and provide expert guidance on regulatory submissions for new products and product modifications, including 510(k)s, PMAs, and combination device applications
Draft, review, and approve technical protocols and data supporting clinical trials, validation, verification, and regulatory submissions
Evaluate regulatory impact of design changes and modifications to cleared products, ensuring compliance with applicable quality and regulatory standards
Guide development and review of product labeling, including Instructions for Use (IFU/PI), to ensure adherence to regulatory requirements
Implement new regulations and standards, and provide training to team members on regulatory compliance
Serve as subject matter expert, advising internal teams on regulatory strategy, clearance processes, and post-clearance activities
Contribute to continuous improvement of regulatory processes and documentation standards