Job opportunity with a top biopharmaceutical company that is looking for a Senior Regulatory Affairs Specialist to join their team on a 6-month contract with a possibility for conversion or extension!
- Requires a bachelor's degree and five years of experience in the medical device industry.
- Strong knowledge of FDA Quality System Requirements (QSR), ISO 13485, MDD 93/42/EEC, and MDR 2017/745.
- Orthopedic or spine experience preferred.
- RAC certification preferred.
- Must have 510(k) submission experience.
- Collaborates as a core team member on new product development teams. Independently determines and documents appropriate regulatory strategies for proposed new products. Supports design control activities.
- Prepares regulatory submissions including 510(k) premarket notifications for US FDA.
- Prepares regulatory submissions including technical files/design dossiers for registration of products in the European Union and interfaces as needed with Notified Bodies regarding significant changes to products.
- Responsible for internal process improvements, data/metric evaluation, maintenance of databases, and public-facing information.
- Assists with post-market surveillance evaluation, trending and reporting including updates to risk management (e.g., FMEA) process.
- Reviews product labeling and promotional materials to ensure consistency with regulatory approvals.
- Health Insurance
Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?