Sr. Manager, Regulatory Affairs

Description

1. Leads team in assessment of regulatory pathways for new and existing products; develops regulatory strategies and plans for submissions to the US and EU.
2. Communicates potential risks and mitigations associated with regulatory strategies to stakeholders and senior management.
3. Manages and develops group of regulatory affairs employees carrying out product submission/registration/renewal/change activities.
4. Delegates, maintains, and updates all necessary lifecycle documentation according to various regulations, including IVDR, and internal procedures.
5. Directs the preparation and filing of regulatory submissions for US clearance and EU IVDR approval.
6. Assists in monitoring regulatory developments affecting BMX programs and products and communicates emerging opportunities and concerns to stakeholders.
7. Directs the regulatory review of labels, labeling, and drives the development of policies to ensure consistency in these reviews.
8. Develops direct reports regarding required competencies, including, but not limited to, regulatory knowledge and ability to apply this knowledge, effectiveness in team and one-to-one interactions, and verbal and written communications.
9. Develops functional processes. Ensures functional skills and competencies are reinforced with appropriate tools and templates.
10. Management of the team and oversees day-to-day responsibilities and workflow. Responsible for interviewing, hiring, and evaluating performance for personnel.
11. Responsible for timesheet approval, PTO approvals, and attendance tracking.

• Bachelor's degree or equivalent. Science background is preferred. Masters degree prefered
• 6+ years in regulatory affairs or equivalent, medical device/IVD industry, including 4+ years leading projects and directly managing a team and/or multiple employees.

• IVD and/or medical device experience required.
• 510(k) and IVDR submission experience required (or equivalent).
• Very strong written and oral communications skills
• Fluent communication in English
• Ability to work well within a multicultural environment.
• Analyze and understand technical and scientific documents.
• Demonstrate initiative and can work both independently and collaboratively in a team structure.
• Ability to think strategically, to detect the principle of complex or ambiguous issues, and to put these in the context of larger, systemic issues.
• Ability to inspire, motivate, and build the confidence of teams to reach goals, consistently pushing self and others to achieve results.
• Proficient with MS Office Suite including Word, Excel, Outlook and PowerPoint
• Demonstrate success in supporting both growth and product support projects, including complex projects involving ambiguity, in a rapidly changing regulatory environment.