Manager, Regulatory Affairs
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Job Description
Manager of Regulatory Affairs providing regulatory strategy for healthcare products in Magnetic Resonance. Working with global regulatory bodies for product launch and compliance in the medical field.
Responsibilities:
- Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally.
- Developing specialized depth and/or breadth of expertise in own job discipline or field.
- Serves as best practice/quality resource.
- Has awareness of latest functional developments in own area.
- Contributes towards strategy and policy development and ensures delivery within area of responsibility.
- Skilled influencer, able to communicate complex messages to others.
- Acts as a resource for colleagues with less experience.
- May lead small projects with moderate risks and resource requirements.
- Explains difficult or sensitive information; works to build consensus.
Requirements:
- Bachelor's Degree in a Scientific or Engineering discipline or a minimum of 8 years work experience
- A minimum of 4 years Regulatory Affairs / Quality Assurance experience
- A minimum of 4 years' experience in the medical device or pharmaceutical industry
- Strong experience with management of regulatory projects in global regulatory organizations and working globally across different cultures
- Excellent verbal and written communication and presentation skills with ability to speak and write clearly and convincingly in English, tailoring communication methods to customer’s requirements.
Benefits:
- medical, dental, vision
- paid time off
- 401(k) plan with employee and company contribution opportunities
- life, disability, and accident insurance
- tuition reimbursement
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