Regulatory Affairs Director jobs in Minnesota

Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Associate Director Regulatory Affairs – Vascular (on-site)
  • 3202 St. Jude Medical Business Services, Inc.
  • Minnesota, MN FULL_TIME
  • 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. JOB DESCRIPTION: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott 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. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO 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. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. The Opportunity This Associate Director Regulatory Affairs will work on-site at our St. Paul, MN location in the Vascular Division. As a manager, the function of an Associate Director Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory professionals. The individual has department level influence and is generally recognized as an expert resource both within Abbott and externally. The individual may comment on changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information. The individual may ensure that data are identified, obtained and effectively presented for the registration of products worldwide. What You’ll Work On Sets strategy and directs preparation of submissions for products to regulatory agencies, and interfaces with agencies in order to obtain timely approval to produce and market new products. Provides guidance on regulatory requirements and strategies to product development project teams. Maintains expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicates such knowledge to all internal stakeholders. Consults with and provides advice to senior management of the Company on strategies and plans for regulatory product approvals. Directs staff in implementing regulatory strategy and preparing regulatory submissions. Remains current on developments in field(s) of expertise, regulatory requirements, as well as industry trends and trains staff regarding changing regulations that affect regulatory submissions. Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences. Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence. Performs related functions and responsibilities, on occasion, as assigned. Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies 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 communication. Required Qualifications Bachelor’s Degree or an equivalent combination of education and work experience 5-7 years’ experience in a regulated industry (e.g., medical products, nutritionals). 5-7 years’ experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience. Preferred Qualifications Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) Experience with U.S. Food and Drug Administration (FDA) Class III/II device regulations and EU MDR regulations. Prior experience managing and coaching a team. Apply Now * Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year. Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. The base pay for this position is $125,300.00 – $250,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: AVD Vascular LOCATION: United States > Minnesota > St. Paul : 1225 Old Highway 8 NW ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 15 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter
  • 1 Month Ago

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Senior Regulatory Affairs Specialist
  • ICONMA, LLC
  • Saint Paul, MN FULL_TIME
  • This position will be working with multiple business units to develop, update, and improve regulatory affair processes. Assist the strategy implementation and operations for regulatory affairs activit...
  • 16 Days Ago

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Regulatory Affairs Specialist
  • USA 3M Company
  • Minnesota, MN FULL_TIME
  • Job Description: Regulatory Affairs Specialist Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career has a major impact on your professional and personal life...
  • 20 Days Ago

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Sr. Regulatory Affairs Specialist
  • Medtronic
  • Minneapolis, MN FULL_TIME
  • Position Description: Sr. Regulatory Affairs Specialist for Medtronic, Inc. Minneapolis, MN. Multiple positions available. Responsible for developing regulatory strategies, preparing U.S. and internat...
  • 1 Day Ago

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Regulatory Affairs Specialist
  • PMT Corporation
  • Chanhassen, MN FULL_TIME
  • Find Fulfillment in Work Every Day! We Offer Careers that Make a Difference.PMT Corporation, located in Chanhassen, Minnesota, is known for manufacturing and distributing high end, innovative products...
  • 5 Days Ago

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Regulatory Affairs Analyst II
  • Danaher
  • Chaska, MN FULL_TIME
  • Wondering what’s within Beckman Coulter? Take a closer look. At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and...
  • 8 Days Ago

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Head of Regulatory Affairs
  • Einride
  • Austin, TX
  • Want to be part of transforming road freight - for good? Einride is showing the world a new way to move, based on the la...
  • 4/24/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Thor Companies
  • Must be able to be on site 3 days per week in the San Francisco Bay Area! Key Responsibilities Provide strategic and ope...
  • 4/24/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Dyne Therapeutics
  • Waltham, MA
  • Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-tran...
  • 4/24/2024 12:00:00 AM

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Head of Regulatory Affairs
  • Exegenesis Bio Inc
  • Ambler, PA
  • Job Description Job Description Job Title: Head of Regulatory Science Reports to (Title): CEO Location: Remote, US Exemp...
  • 4/23/2024 12:00:00 AM

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Sr. Director of Regulatory Affairs
  • Accordance Search Group
  • Cambridge, MA
  • What this position is all about: We are looking for a strategic and results-driven Head of Regulatory Affairs (level com...
  • 4/23/2024 12:00:00 AM

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Head of Regulatory Affairs
  • Accordance Search Group
  • Somerville, MA
  • What if you could join a company rapidly advancing its first candidate to clinic and play a critical role in bringing ne...
  • 4/22/2024 12:00:00 AM

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Regulatory Affairs Director
  • Hiring Now!
  • Boston, MA
  • About the Job The Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehens...
  • 4/21/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Atrium Medical
  • Hudson, NH
  • Position Specific Requirements: Responsible for internal, domestic, and international compliance activities working unde...
  • 4/21/2024 12:00:00 AM

Minnesota (/ˌmɪnɪˈsoʊtə/ (listen)) is a state in the Upper Midwest and northern regions of the United States. Minnesota was admitted as the 32nd U.S. state on May 11, 1858, created from the eastern half of the Minnesota Territory. The state has a large number of lakes, and is known by the slogan the "Land of 10,000 Lakes". Its official motto is L'Étoile du Nord (French: Star of the North). Minnesota is the 12th largest in area and the 22nd most populous of the U.S. states; nearly 60% of its residents live in the Minneapolis–Saint Paul metropolitan area (known as the "Twin Cities"). This area i...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$172,914 to $246,269

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At the Healthcare Professionals Group, our experienced team of Regulatory & Quality recruitment consultants are ready to discuss a variety of Regulatory Affairs Director jobs with you.
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The regulatory affairs director might engage in reading and responding to letters from the FDA, including any “warning letters” about unapproved activities or products.
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Regulatory Affairs Director in Richmond, VA
The office of regulatory affairs is a dynamic work environment where communication with employees at all levels within the organization is extremely important.
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