Abbott ASSOCIATE DIRECTOR, REGULATORY AFFAIRS in Abbott Park, Illinois
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 107,000 colleagues serve people in more than 160 countries
Our location in Abbott Park, IL currently has an opportunity for an Associate Director, Regulatory Affairs.
As an individual contributor, the role of an Associate Director, Regulatory Affairs in Abbott’s corporate Global Strategic Regulatory department is to combine knowledge of scientific, regulatory and business issues to support Abbott’s diagnostic businesses in premarket activities with the U.S. Food and Drug Administration. The individual will provide strategic direction and technical guidance on regulatory requirements to a variety of Abbott’s development teams driving premarket strategies that lead to robust submissions and timely product approvals.
The successful candidate will possess strong knowledge of FDA regulations and guidance documents pertaining to the regulation of in vitro diagnostics (IVD) and will be responsible for leveraging that expertise to support Abbott’s premarket objectives.
WHAT YOU’LL DO
Utilize technical regulatory skills to propose positioning strategies on moderately-complex premarket issues.
Provide recommendations on the organization and content of pre-submissions, submissions, interactive review responses, and deficiency responses.
Identify premarket trends and ensure consistent approach across Abbott’s businesses, where appropriate.
Serve as regulatory subject matter expert throughout product lifecycle.
Manage projects involving multiple businesses and functional stakeholders.
Critical Success Factors
Influence/Leadership · Develops, communicates, and builds consensus for premarket strategies that are in alignment with Abbott’s objectives, sound scientific principles, and regulator expectations · Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units · Builds strong relationships with business partners and stakeholders and leverages relationships to tactfully influence and gain their support to drive desired outcomes · Exercises judgment independently.
Anticipation/Planning · Holistic, big picture thinker, who anticipates changes in regulation, regulator expectations, and/or business objectives and adapts approach as necessary to manage risks effectively and drive timely approval or clearance of Abbott’s IVD products · Creates immediate to long-range plans to carry out objectives established by senior management.
Decision Making/Impact · Assignments are expressed in the form of objectives · Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management.
Collaboration · Firm understanding of available regulatory and business resources and ability to integrate information from a number of sources to achieve business results, including breaking down boundaries to create alignment as necessary, in a complex, matrixed environment.
EDUCATION AND EXPERIENCE, YOU’LL BRING
Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields preferred.
M.S. in a technical area or M.B.A. preferred but not required.
Certification is a plus ( e.g. , RAC from the Regulatory Affairs Professionals Society.)
7+ years of experience in a regulated industry required ( e.g. , medical devices, diagnostics, pharmaceuticals); experience in in-vitro diagnostics (IVD) preferred but not required.
7 + years of experience in regulatory function preferred but may consider experience in quality assurance, research and development/support, scientific affairs, operations, or related area.
Regulatory knowledge of:
FDA regulations, guidance and policies;
Regulatory agency structure, processes and key personnel; and
Ethical guidelines of the regulatory profession, clinical research and regulatory process.
Must have ability to handle multiple projects in fast-paced environment and exercise sound judgment.
In addition to top-notch technical expertise, must have excellent interpersonal, strategic thinking, communication and organizational skills.
- Experience interacting and negotiating with FDA, specifically CDRH’s OHT7: Office of In Vitro Diagnostics and Radiological Health.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
Training and career development , with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
*Learn more about our benefits that add real value to your life to help you live fully: * www.abbottbenefits.com at http://www.abbottbenefits.com/pages/candidate.aspx
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com at http://www.abbott.com/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org