At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. The Senior Regulatory Specialist will support product development and regulatory activities, interacting with FDA and other regulatory agencies to expedite approval of pending registration. The role requires a bachelor's degree and 5 years of experience in a medical device industry with regulatory experience.
Requirements
- Bachelors Degree (± 16 years) Technical discipline highly preferred OR an equivalent combination of education and work experience
- Minimum 5 years Technical experience, including at least 4 years of regulatory experience in a medical device industry.
- Experience with 510(k) applications, PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communication with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organization and follow-up skills, as well as attention to detail.
- Ability to travel approximately 5%, including internationally.
- Masters Degree (± 18 years), In Regulatory Affairs preferred and may be used in lieu of direct regulatory experience.
- Minimum 3 years, 3-4 years experience in a regulated industry (e.g., medical products, nutritionals). 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
- Experience with review of labeling, promotional, and or advertising materials is highly desired
- Familiar with Principles and requirements of promotion, advertising and labeling.
- Office program skills to include Word, Excel, PowerPoint, Adobe Acrobat and SharePoint.
- Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields. Master’s Degree in Regulatory Affairs and may be used in lieu of direct regulatory experience.
Benefits
- Career development with an international company where you can grow the career you dream of
- Employees can qualify for 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 - an affordable and convenient path to getting a bachelor’s degree
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists
