About the role
Associate Director Regulatory Affairs -Diabetes Care role based on the published job description. Key responsibilities and requirements were extracted directly from the posting for quick review.
HealthcareOnsite
Key Responsibilities
- We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions.
- We're revolutionizing the way people monitor their glucose levels with our new sensing technology.
- MAIN PURPOSE OF ROLE The function of an Associate Director Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured and distributed to meet required legislation.
- Additionally, the individual will develop and supervise regulatory professionals.
- The individual has division level influence and is generally considered a key opinion leader and an expert resource both within Abbott and externally.
- The individual will influence changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information.
Requirements
- Bachelor's Degree in a scientific discipline (e.g., biomedical engineering,pharmacy, chemistry, pharmacology, life science.)
- A relevant Masters Degree is preferred.
- At least 2-3 years global experience.
- 7+ years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
- Experience in nutrition/medical device/pharmaceutical industry and international business.
- Expertise in due diligence, Company integration and rationalization of manufacturing facilities from the regulatory perspective Must have the ability to convince division management at all levels to support the regulatory needs.