Overview
We are seeking a motivated and detail-oriented Medical Device Senior Regulatory Affairs Specialist with 3-5 years of hands-on experience to join our team. In this role, you will support the regulatory strategy and compliance activities for medical devices throughout the product lifecycle. You will play a key role in preparing and maintaining regulatory submissions, ensuring adherence to global standards, and facilitating timely market access while collaborating closely with cross-functional teams including R&D, Quality Assurance, Clinical, Operations and Marketing. High growth potential for the right candidate.
Key Responsibilities
- Prepare, review, and submit regulatory filings to the FDA (510(k), PMA, De Novo, IDE) and international authorities (EU MDR/IVDR, Health Canada, etc.).
- Maintain and update Technical Documentation, Design Dossiers, and regulatory files to ensure ongoing compliance.
- Support product registrations, renewals, and post-market surveillance activities globally.
- Conduct regulatory assessments for product changes, labeling, and promotional materials.
- Collaborate with internal teams to ensure regulatory requirements are integrated into product development and lifecycle management.
- Monitor and interpret evolving regulatory landscapes (FDA, EU, ISO 13485, etc.) and communicate impacts to the organization.
- Assist in internal and external audits, including FDA inspections and Notified Body audits.
- Prepare and maintain regulatory strategies, risk management files, and clinical evaluation reports.
- Support complaint handling, vigilance reporting, and post-market surveillance activities.
- Participate in cross-functional project teams to drive regulatory timelines and deliverables.
Qualifications and Experience
Education: Bachelor’s degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, or a related field.
Experience: 3-5 years of progressive experience in regulatory affairs specifically supporting medical devices (Class II and III preferred).
Strong working knowledge of U.S. FDA regulations (21 CFR Part 820, 510(k), QSR) and international standards (EU MDR 2017/745, ISO 13485, ISO 14971).
Experience with eCTD or electronic submissions is a plus.
RAC (Regulatory Affairs Certification) or similar credentials is highly desirable.
Required Skills and Competencies
- Excellent written and verbal communication skills with the ability to prepare clear, concise regulatory documentation.
- Strong analytical and problem-solving abilities with high attention to detail.
- Proven ability to manage multiple projects and deadlines in a fast-paced environment.
- Proficiency in Microsoft Office Suite and regulatory submission software/tools.
- Ability to work independently and collaboratively within a team environment.
- Strong organizational skills and project management experience.
Join us in advancing brachytherapy innovation! This role offers a vibrant environment where your expertise directly impacts patient safety and device efficacy worldwide. We value proactive problem-solvers who thrive in fast-paced settings and are passionate about improving health outcomes through cutting-edge radioactive technology.
Pay: $69,244.73 - $99,305.49 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
