Description

Job Summary

The Regulatory Affairs Manager will work with a high level of autonomy to oversee the regulatory processes of lifecycle and change management while managing a regulatory team. This person will contribute to the development of regulatory strategy and conduct assessments of regulatory changes and/or risks throughout the life cycle of the product.

Essential 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.
• Manages and develops small 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 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.
• Assists with the regulatory review of labels, labeling, and assists with 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 small 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.

Supplemental Data

• < 2-8 Direct Reports
• < 15% Travel required.
• 95% WFH Options Available/ Remote options available

Qualifications

Training and Education

Bachelor’s degree or equivalent. Science background is preferred. Advanced secondary degree a plus.

Experience

6+ years in regulatory affairs or equivalent, medical device/IVD industry preferred, including 2+ years leading small projects and mentoring other employees.

Knowledge, Skills, and Abilities

• 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.

Physical Requirements

Ability to work in an office/desk environment for 40 hours/week