Senior Regulatory Affairs SpecialistWe're actively seeking qualified candidates for a
Senior Regulatory Affairs Specialist opportunity supporting medical device regulatory submissions and compliance.
Key Responsibilities- Prepare, coordinate, and manage regulatory submission documentation, including 510(k) submissions and EU MDR technical documentation.
- Develop regulatory submission strategies to support product approvals and market access.
- Compile documentation for regulatory submissions, license renewals, annual registrations, audits, and inspections.
- Evaluate labeling, manufacturing, marketing, and clinical documentation for regulatory compliance.
- Monitor regulatory requirements, guidance, and changes in applicable standards.
- Collaborate cross-functionally with Engineering, Quality, Clinical, and other stakeholders to achieve regulatory objectives.
- Identify opportunities to improve regulatory processes, documentation, and tracking systems.
- Provide regulatory guidance and recommendations to support timely approvals.
Required Qualifications- Bachelor's degree in a scientific discipline or equivalent.
- 5-8 years of relevant regulatory affairs experience.
- Demonstrated experience developing and writing 510(k) and EU MDR submissions, including regulatory strategy.
- Experience with electrical medical devices and IEC 60601 standards.
- Strong written and verbal communication skills.
- Proven ability to work independently, take ownership of deliverables, and collaborate effectively across cross-functional teams.
Position Details- Location: Jacksonville, FL preferred; remote candidates may be considered based on experience.
- Schedule: Full-time, 40 hours per week.
- Position Type: Contract.
If you have strong medical device regulatory affairs experience and a background in 510(k) submissions, EU MDR, and IEC 60601, we'd like to hear from you!
#LI-KS1
