For years, Abbott's medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it's glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier.
Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine finger sticks.
WHAT YOU'LL DO
In this key leadership role, you will be responsible for planning, creating and implementing solutions for the regulatory release of products for distribution into specific geographies. This is an environment where you can add value while enjoying complexity and variety every day. You will have three general areas of responsibility:
- Strategic, including people leadership, training and development
- Tactical, including day to day execution on KPIs
- Managing blocked orders, resolving escalated issues cross-functionally
- Product Release Authorizations and Release for Distribution
- Oversee processes and team involved with obtaining and maintaining product release authorization and release of product to specified geographies.
- Coordinate with cross functional teams including but not limited to: US Regulatory, International Regulatory, Marketing / PLC, Supply Planning, Customer Service, etc. to ensure all internal and external requirements are met prior to product release.
- Product Release Process Ownership
- Develops processes and tools to support controlled product release.
- Responsible for development, maintenance and compliance with applicable Corporate and Divisional Policies and procedures.
- Product Release Authorization and Release Planning
- Provide Regulatory Operations input to product lifecycle planning and input to strategy based upon regulatory changes
- Identify and react to emerging issues
- Analyze product-associated problems and develop proposals for solutions.
- Act as a liaison with other departments, e.g., Quality, R&D, Legal, Operations, Marketing and Clinical Affairs, for major initiatives.
- Hire and retain a diverse, highly qualified staff, providing ongoing performance feedback and maintaining a safe and professional work environment.
- Support Company initiatives in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Comply with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Represent Global Regulatory Operations to various groups and teams.
EDUCATION AND EXPERIENCE YOU'LL BRING
- Bachelor's Degree (Biology, Chemistry, Microbiology, Immunology, Medical Technology, Pharmacy, Pharmacology or related)
- 8+ years of experience, including a minimum of 5 years experience in regulated industries.
- Regulatory Operations CAPA experience, including working cross-functionally to complete investigations, root cause analysis, action planning, implementation and verifications of effectiveness.
- People / team leadership experience. Ability to manage team capacity and capabilities to ensure that demand is met with expected service levels.
- Advanced level degree
- SAP and Windchill or comparable systems knowledge
- Ability to leverage existing functionality (systems, tools and data) to drive process improvements.
- Ability to influence cross-functionally to achieve enterprise objectives.