Sr Manager, RA Life Cycle Management - Biofire
Hazelwood, MO
About the Job
The Sr. Regulatory Affairs Manager will work with a high level of autonomy to oversee the regulatory processes of lifecycle and change management while managing the entire LCM regulatory team in the Americas. This person will lead and contribute to the development of regulatory strategy linked with Change Management and conduct assessments of regulatory changes and/or risks throughout the life cycle of the product.
Position is located in Salt Lake City, UT or St Louis, MO
Job Duties and Responsibilities
- Leads team in assessment of potential regulatory pathways for product modifications; develops regulatory strategies and plans for submissions global regulatory agencies.
- Communicates potential risks and mitigations associated with regulatory strategies to stakeholders and senior management.
- Manages and develops 5 regulatory affairs employees carrying out product change activities.
- Delegates, maintains, and updates all necessary lifecycle documentation according to various regulations, including IVDR, and internal procedures.
- Directs the preparation and filing of regulatory change submissions for regulatory agency approval.
- Assists in monitoring global regulatory developments affecting BMX programs and products and communicates emerging opportunities and concerns to stakeholders.
- Directs the regulatory review of labels, labeling, and drives the development of policies to ensure consistency in these reviews.
- 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.
- Develops functional processes. Ensures functional skills and competencies are reinforced with appropriate tools and templates.
- Management of the team and oversees day-to-day responsibilities and workflow. Responsible for interviewing, hiring, and evaluating performance for personnel.
- Responsible for timesheet approval, PTO approvals, and attendance tracking.
Minimum Qualifications:
- Bachelor’s degree or equivalent. Science background is preferred. Advanced secondary degree a plus.
- 6+ years in regulatory affairs or equivalent, medical device/IVD industry preferred,
- 3+ years leading projects and directly managing a team and/or multiple employees.
Knowledge, Skills:
- 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.
Source : Biofire