What are the responsibilities and job description for the Regulatory Affairs Manager position at BioPhase?
- Fully onsite - candidates must be located in San Diego, CA
Summary:
The Regulatory Affairs Manager oversees regulatory compliance and submissions for in vitro diagnostic (IVD) products. They manage a team to develop regulatory plans, prepare submissions (e.g., 510(k), IVDR Technical Documentation), and maintain communication with global regulatory agencies. The role includes assessing market authorization impacts, reviewing promotional materials, and driving continuous improvement initiatives.
Key Responsibilities:
- Regulatory Strategy & Compliance: Develop and execute regulatory plans for new and existing products across multiple geographies (U.S., EU, Canada, etc.). Ensure compliance with evolving regulations.
- Submissions & Approvals: Oversee and assist in regulatory submissions, impact assessments, and communications with agencies such as the FDA and EU Notified Bodies.
- Cross-functional Collaboration: Work with R&D, Marketing, Quality Assurance, and Manufacturing to align regulatory strategies with business objectives.
- Regulatory Intelligence: Monitor industry regulations, provide insights to senior management, and implement compliance strategies.
- Department & Team Management: Lead, mentor, and develop the Regulatory Affairs team, manage budgets, and ensure adherence to company policies and quality systems.
Qualifications:
- Bachelor's in bioengineering, biochemistry, molecular biology, or related field (Advanced degree preferred).
- 8 years in Regulatory Affairs (5 in IVD), with 5 years in team management.
- Working knowledge of regulatory requirements for obtaining global Regulatory Approvals in Asia Pacific, Latin America and Middle East.
- Strong knowledge of regulatory requirements for obtaining Regulatory Approvals in the United States, EU (under IVDR), Canada, and Australia.
- Understanding of CLSI guidelines preferred.
- Strong knowledge of regulatory requirements in major global markets, hands-on experience with regulatory submissions, and cross-functional project leadership.
- Strong scientific writing, communication, and leadership abilities.
- Proficiency in regulatory requirements, data analysis, and product validation.
- Advanced Microsoft Office skills and experience with electronic publishing systems.
Salary : $145,000 - $160,000
