What are the responsibilities and job description for the Sr. Manager, Regulatory Affairs position at BioFire Diagnostics, LLC?
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Description
The Sr. Regulatory Affairs Manager will work with a high level of autonomy to oversee the regulatory processes of new product development while managing a regulatory team. This person will lead and contribute to the development of new products and regulatory strategy and conduct assessments of regulatory changes and / or risks throughout the life cycle of the product.Position is located in SLC. It is 95% virtual and candidate is required to go into the SLC office. Essential Job Duties and Responsibilities
- Leads team (3 – 4 direct reports) in assessment of regulatory pathways for new and existing products; develops regulatory strategies and plans for submissions to the US and EU.
- Communicates potential risks and mitigations associated with regulatory strategies to stakeholders and senior management.
- Manages and develops group of regulatory affairs employees carrying out product submission / registration / renewal / 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 submissions for US clearance and EU IVDR approval.
- Assists in monitoring 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 Requirements
Knowledge and Skills
