We are seeking a talented, self-led, and energetic Sr. Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist is responsible for managing the complaint handling unit (CHU) functions. Provide hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements/strategies and preparation of submission. The position will be interfacing with regulatory bodies, third party consultants, marketing and management, and assist in developing ideas for solutions consistent with our submission roadmap.
- Assist with 510ks that are going in this year
- Support the updating procedures, SOPs and deliverable with EU-MDR
- Complete worldwide regulatory assessments and strategies as required to support assigned projects and provide direction to project teams to support strategic new product development and product modifications as required
- Provide direction on application of external standards for assigned projects as required
- Execute product submission strategies as directed
- Maintain all regulatory documentation to ensure availability for a audits and preparation of submission packages
- Bachelor's degree in Science or Engineering or a combination of education and experience providing equivalent knowledge
- Minimum of 6-8 years' experience in Regulatory Affairs
- Minimum of 5 years medical device industry experience
- Working knowledge with quality system regulation and guidelines
- Through understanding of FDA and international submission requirements including how to comply with standards and regulations
- RAC Certification preferred
Sthree US is acting as an Employment Business in relation to this vacancy.