Manager, Regulatory Affairs - Apac

• Contribute to strategic direction of Regulatory Affairs department.
• Manage and support career development of direct reports.
• Lead interaction with regulatory agencies or regulatory bodies.
• Provide oversight and guidance on Regulatory Affairs processes.
• Serve as regulatory subject matter expert for cross-functional teams.
• Provide guidance for strategy and direction of projects represented by direct reports.
• Manage RA functional area in the review, assessment of changes and approval of change orders.
• Work with departments to locate information necessary to support regulatory submissions and identify gaps in testing.
• Lead Regulatory Affairs specialists as partners to cross-functional teams supporting new product development and sustaining projects.
• Oversee regulatory submissions/applications for US FDA class II/III devices, including IDEs, 510(k)s, pre-subs, PMAs (including PMA Supplements and Amendments).
• Oversee regulatory consultants and registrars.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in a life science or related field preferred, or an
• Equivalent combination of education and experience to perform at this level.
• Minimum of 5 years of experience in premarket Regulatory Affairs within the medical device industry.
• Interpret subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations.
• Minimum of 1 year of clinical or quality functional experience
• Self-directed to see issues through to completion.
• Detail oriented with well-developed analytical and problem-solving skills.
• Excellent, proven interpersonal, verbal, and written communication skills.

Inari Medical offers competitive health and wealth benefits for our employees. The base pay range for this position is $125,000 - $145,000. A range of factors, including location, skills, and experience, will be considered. Actual compensation may vary.