What are the responsibilities and job description for the Senior Regulatory Specialist position at Exactech?
Department: Regulatory
Location: US (Remote)
The purpose of the Senior Regulatory Specialist is to provide services to fulfill the regulatory requirements necessary to achieve global regulatory approvals / clearances and maintain overall regulatory compliance for the company.
Key Responsibilities
- With minimal oversight, preparing and maintaining pre-market submissions or post-market change submissions for a variety of markets.
- With minimal oversight, provide project-level regulatory strategy and support for new product development projects, post-market lifecycle projects, Quality System updates, business development projects:
- Project team RA lead member
- Assess and approve post-market changes
- Assess and approve product and process Nonconformances and deviations
- Own and execute CAPA for Regulatory processes
Education:
- Bachelor’s Degree from an accredited institution required.
- Minimum 5 years experience in FDA/ISO medical devices quality management system standards required
- 5 years experience in FDA pre-market submissions (510(k) and/or PMA) and international product registrations required
- Technical writing skills required