Regulatory Affairs Manager
Carlsbad – US
What we value:
- Honesty & Integrity: Uphold ethical standards and a strong work ethic.
- Passion & Curiosity: Show enthusiasm for medical device engineering and continuous learning.
- Problem Solving & Learning Ability: Demonstrate problem-solving skills and seek professional growth.
Key responsibilities:
- Provides regulatory support for diagnostic product development and commercial diagnostic products.
- Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the US and internationally.
- Writes, edits, and reviews submission documents; compiles and publishes required materials for submissions, renewals, and registrations.
- Maintains approvals/licenses for existing marketing authorizations and ensures US registration and device listing accuracy.
- Represents Synaptic Medical on US trade associations and contributes to trade positions.
- Contributes to reviews of new/revised regulations and assists with inspections and audits.
What we are looking for:
- Bachelor’s degree in a scientific, engineering, or related field. Advanced degree or certification in Regulatory Affairs (e.g., RAC) is a plus.
- Minimum of 5 years of regulatory affairs experience in the medical device industry, with a focus on premarket submissions.
- Proven track record of successful regulatory submissions and product approvals.
- Strong knowledge of regulatory requirements and guidelines, including FDA, ISO, and EU MDR.
- Hands-on experience with regulatory submissions, including 510(k), and CE marking. PMA is a big plus.
What we offer:
- Impactful work in medical devices.
- Collaborative environment and career development.
- Comprehensive benefits, including medical, dental, vision, retirement, PTO, parental leave, and disability support
