Title: Senior Specialist, Regulatory Affairs
Summary: A leading medical technology company specialized in innovative spinal medical devices is looking for a Senior Specialist, Regulatory Affairs to join their team! This company designs and develops neuro-monitoring equipment and x-ray machine software to effectively improve medical technology in the spinal surgery space and meet patient needs in a safe and efficient way.
Responsibilities:
- Prepare global medical device regulatory submissions, including but not limited to, technical files, registration of products and responsibility of internal process improvements
- Assist with post market surveillance evaluation and updates to risk management with new and existing products
- Review product labeling and promotional materials for regulatory approvals
- Take initiative with leadership by competition of projects
Qualifications:
- 5+ years of regulatory experience
- Written 510(k) submission experience
- Orthopaedic or spine experience preferred
- Strong technical writing skills
Benefits:
- 401K match with stock purchase programs
- Paid Sick Leave, Vacation Leave and Floating Holidays
- Hands on training for new employees to build skills and company specific knowledge
- Employer-funded allowance for transportation
If you, or anyone in your network, is interested in this Regulatory Affairs Senior Specialist position, please do not hesitate to apply! 😊