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Manager, Regulatory Affairs

Employer
Abbott Laboratories
Location
Saint Paul
Salary
Competitive

View more

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 109,000 colleagues serve people in more than 160 countries.

Manager, Regulatory Affairs - Plymouth or St. Paul, MN

ABOUT ABBOTT

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of STRUCTURAL HEART disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.

WHAT YOU'LL DO

We are recruiting for a Manager, Regulatory Affairs to join our team in the Plymouth or St. Paul, MN location. In this role, you will have the opportunity to develop, implement and lead both regional and international strategy for assigned projects with various cross-functional teams. You will execute regulatory strategies for earliest possible approvals of the company's regulatory applications at all stages of development and post approval, provide guidance for, and contribute to, the development of documents for regulatory agencies (e.g. IDE/PMA/510k/EU submissions), as well as ensuring that they meet current regulatory requirements and industry standards, are high quality, consistent, complete, and approvable on the first review cycle. Additionally, you will be leading and providing guidance for a small team of regulatory professionals.

Responsibilities:

* Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams. Monitor trade association positions for impact on company products.

* Monitor impact of changing regulations on submission strategies and update internal stakeholders. Monitor applications under regulatory review. Communicate application progress to internal stakeholders. Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities.

* Utilize technical regulatory skills to propose strategies on complex issues. Determine submission and approval requirements. Identify emerging issues

* Prepares robust regulatory applications to achieve departmental and organizational objectives.

* Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. Provides guidance and expertise.

* Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel

* Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams. Monitor trade association positions for impact on company products.

* Monitor impact of changing regulations on submission strategies and update internal stakeholders. Monitor applications under regulatory review. Communicate application progress to internal stakeholders. Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities.

* Utilize technical regulatory skills to propose strategies on complex issues. Determine submission and approval requirements. Identify emerging issues

* Prepares robust regulatory applications to achieve departmental and organizational objectives.

* Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. Provides guidance and expertise.

* Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel

EDUCATION AND EXPERIENCE YOU'LL BRING

Required

* Bachelor's Degree in Engineering, Sciences, or related discipline

* 5+ years of related work experience in a similar role, including writing/submitting, reviewing PMA, 510k, IDE submissions approval experience, and/or knowledge of FDA/EU regulations, practices, and procedures

* Demonstrated experience building strategic partnerships to further departmental and organizational objectives

* Ability to work within a team environment and/or as a senior individual contributor leveraging and/or engaging others to accomplish projects within a fast-paced, matrixed environment.

* Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

* Proficient with MS Office (Word, Excel, Outlook)

Preferred

* Advanced degree in Engineering, Sciences, or related discipline

* Experience with 510(k) applications, PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions

* Previous experience working in a broader enterprise/cross-division business unit mode

* Lead functional groups in the development of relevant data to complete a regulatory submission

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:

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.

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