About the position
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. The opportunity is for a Senior Regulatory Affairs Manager - Transcatheter Mitral Valve Replacement within Abbott Ventures, located in Santa Clara, CA. This individual will lead and coordinate global Regulatory Affairs activities including regulatory strategies, submissions to support clinical trial activities and product launches. The Senior Manager leads project submissions for regulatory approvals and acts independently to identify and resolve problems. This individual applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of programs.
Responsibilities
- Recruit, coach and develop Regulatory Affairs talent.
- Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of Regulatory Affairs and organizational objectives.
- Develops and implements regulatory strategies that will ensure earliest possible introduction of new product(s) into domestic and international markets.
- Provides direction and guidance to exempt and non-exempt Regulatory Affairs specialists.
- Keeps the organization's vision and values at the forefront of decision making and action.
- Demonstrates effective change management and leadership.
- Builds strategic cross functional partnerships to further Regulatory Affairs and organizational objectives.
- Monitors compliance with company policies and procedures.
- Makes decisions regarding work processes or operational plans and schedules to achieve functional objectives.
- Develops regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives.
- Assesses proposed new or updated regulations and communicates new requirements to the organization.
Requirements
- Bachelor's Degree in a related field or an equivalent combination of education and experience.
- 9 years' related work experience.
- Providing direction and monitoring progress of exempt specialists and/or non-exempt staff toward accomplishment of business and Regulatory Affairs goals.
- Mentoring and developing Regulatory Affairs specialists.
- Identifying process improvements and participating in development and execution of improvement activities.
- Monitors costs of projects and resources within department.
- Has broad knowledge of various technical alternatives and their potential impact on the business.
- Investigates and solves problems that impacts the work and team.
- Thinks analytically with good problem-solving skills.
- Develops and communicates a clear vision for the team.
Nice-to-haves
- Bachelor's degree in scientific or engineering related disciplines.
- Master's degree or additional professional training in regulatory affairs (such as RAC from the Regulatory Affairs Professionals Society).
- 7 or more years of global regulatory submission experience.
- 2 or more years of people management experience.
- Working within a quality management system (QMS) with a clear understanding of the product lifecycle management and activities.
- Understanding of, and ability to interpret and apply, relevant information related to domestic and international regulatory guidelines, policies and regulations.
- Supporting pre-market and post-market cross functional teams.
- Assessing the regulatory impact of labeling, manufacturing and design changes for IDE approved products, 510(k) or PMA products and EU MDR certified products.
- Authoring PMA and/or IDE supplements, Pre-submissions, 510(k)s, EU substantial and non-substantial change notifications.
- Experience working with medical devices for the treatment of heart disease.
Benefits
- Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with high employer contribution.
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit.
- Recognized as a great place to work in dozens of countries.
- Named one of the most admired companies in the world by Fortune.
