Overview In this role you will steer regulatory affairs for medical devices and biologic products, including HCT/Ps, by shaping strategies and submissions to the FDA and international regulators. You will partner with process development, manufacturing and quality teams to support domestic and international filings, and oversee regulatory documentation, labeling reviews, and compliance with QSR, cGMP, and global standards. This position offers impact across product lifecycle and opportunities to lead cross-functional regulatory initiatives, contributing to safer patient solutions and cost-conscious healthcare. You will drive regulatory strategies and ensure timely, compliant submissions that enable a
Compensation / Benefits- 401k with generous employer match
- Comprehensive medical, dental, vision
- FSA/HSA options
- Company paid insurances (short/long term, life)
- Paid maternity and parental leave
- Education assistance policy ($5,000 per year)
Responsibilities- Develop regulatory strategies and submissions for new/modified products to FDA and international bodies
- Collaborate with process development, manufacturing and quality to prepare domestic and international regulatory submissions
- Write, review and edit technical reports and regulatory documentation
- Provide input on protocols and reports (process validation, equipment qualification, shelf-life)
- Ensure regulatory compliance with QSR and cGMP; monitor ICH, FDA, EU requirements
- Evaluate changes for filing requirements and impact on AATB certifications, state licenses, and FDA registrations
- Review labeling changes, advertising and promotional material
- Review complaints for MDR requirements and potential BPDR events
Key requirements- BS degree in science/technology/engineering/mathematics
- 5+ years regulatory affairs experience in biotech
- 3+ years developing regulatory strategies and preparing submissions
- Experience with regulatory product lifecycle management
- Regulatory experience with medical device and biologic products; PMA/IND/BLA/510(k) exposure
- Strong knowledge of relevant regulations and industry standards
- Excellent organizational, interpersonal and written/verbal communication skills
- Experience with product development and manufacturing
- Strong organizational skills
- Interpersonal and written/verbal communication
- Ability to lead meetings and present regulatory strategies
- Regulatory submissions for PMA/IND/BLA/510(k)
- QSR and cGMP compliance
- FDA and international regulatory knowledge (ICH, EU)
