An exciting opportunity has arisen for a Specialist in Regulatory Affairs to join a rapidly growing medical device company in California.
The successful candidate will be working with a collaborative team, who are pioneering the development of minimally invasive vascular devices.
Key objectives include obtaining regulatory approvals and ensuring compliance to FDA and international regulatory requirements.
If you are interested in joining an innovative company, who are striving to develop new technologies to complement an existing product range, then this could be a perfect fit.
- Responsible for developing regulatory submissions and dossiers, ensuring devices are approved in the assigned market(s).
- Recognise regulatory requirements for commercialization within desired market(s).
- Liaise with regulatory bodies on all matters, ensuring a record of communication is documented.
- Maintain regulatory files and records.
- Partner with cross functional teams to coordinate regulatory strategy.
- Review change order documents and identify impact on current regulatory approvals.
- Review any labeling or promotional material for regulatory compliance.
- Assist with developing or amending regulatory processes.
- Support training for global regulatory processes and system implementations.
- Build team cohesiveness by influencing and mentoring junior team members.
- Perform other duties and responsibilities as assigned.
- BA/BS degree educated
- Minimum of 5 years of professional regulatory experience.
- Track record in preparation of U.S. submissions and Design Dossier application.
- Experience liaising with relevant regulatory authorities
- Experience in Humanitarian Device Exemption (HDE), Investigational Device Exemption (IDE), and Pre-Market Approval (PMA) applications submission.
- 401(k) match
- Excellent health coverage
- PTO over Christmas (in addition to normal holiday allowance)
For more information about this role, please contact Abigail Prudhoe at firstname.lastname@example.org or call +44 782 550 2645
Whilst we may not be able to respond personally to each applicant, we appreciate the time you have taken to consider and apply for a new role with us. If you have not heard from us within 4 weeks, then on this occasion your application has not been successful.