$140,000 - $170,000
21 days ago
Regulatory Affairs Manager
This is an opportunity for an ambitious Regulatory Affairs professional that wants to use all their experience to be join the US operations of an established IVD company at it’s infancy, under the guidance and mentorship of seasoned veterans in the diagnostics space. With a great portfolio already marketed across Europe, the team based just outside of Boston are focusing on gaining 510(k) clearances on the existing product line, as well as the exciting pipeline of assays in development.
- Focused primarily on the new product submissions of assays to support the recently launched platform, you’ll be working on gaining 510(k) and EUA approvals.
- Create templates for new regulatory submissions when required and then write, prepare, edit, and review FDA submissions for IVD products.
- Review clinical and analytical protocols and reports for regulatory content.
- Create and maintain regulatory filing repository as required and publish electronic regulatory filings, ship final packages to regulatory agencies.
- Review labelling, marketing/promotional materials, and other documents for regulatory compliance
- Collaborate with subject matter experts in various functional groups to compile necessary submission materials.
- Support and eventually, as the team grows, lead regulatory interactions for the team; including pre-submission teleconferences or face to face meetings, as well as responses to regulatory inspections and regulatory submission review inquires.
- 5 years’ experience in Regulatory Affairs in Life Sciences (Medical Device, Biotech, Pharma) with previous exposure IVD regulations.
- Bachelor’s degree life science or an applicable regulatory field of study
- Previous experience with 510(k) and PMA submissions for IVD devices
- Strong attention to detail and organizational skills
- Experience and interest in mentoring junior team members and managing direct reports
- An ambitious and motivated mindset, with a self-starter personality and willingness to work autonomously as the US operations plan to grow rapidly.
- Experience managing multiple regulatory submissions simultaneously
- Demonstrated ability to meet project deadlines in a fast-paced start-up environment
- Excellent time management skills and ability to prioritize multiple tasks
- Excellent interpersonal skills and demonstrated ability to collaborate with cross-functional teams
- Understanding of HIPAA and protection of human research participants
- Must be legally authorized to work in the United States without required sponsorship
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.