Director, Regulatory Affairs

Job ID: Posted: Posted TodayStart Date: Location: United States - Illinois - Abbott Park, United States of AmericaTime Type: Full timeAbbott 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 122,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:Working at AbbottAt 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 ofEmployees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar yearAn excellent retirement savings plan with high employer contributionTuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degreeA 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 FortuneA 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 scientistsThe OpportunityThe Director, Regulatory Affairs provides leadership, direction and support for regulatory policy and cross-business regulatory initiatives within the company, actively influencing changing regulations and guidance affecting the company through participation on trade associations and interfaces with regulatory agencies. This person will direct activities associated with capturing domestic and international information both internal and external that impacts the quality, regulatory, and compliance areas of Abbott and keep management abreast of regulatory changes and the impact they could have on the organization. Also, this person will direct and manage cross-business regulatory activities designed to address emerging regulatory issues, incorporate strategic action, and advance the development of Abbott regulatory professionals. This person will be a subject matter expert in the regulatory area organization and serve as a resource that others within the organization can approach for guidance.What You’ll Work OnRegulatory Intelligence:Gather, assess, summarize, and disseminate available regulatory information, such as proposed rules and guidanceDevelop in conjunction with relevant internal stakeholders, draft, and submit directly to regulatory agencies and trade associations the Abbott position/response to proposed device regulatory policyImplement processes for monitoring and communicating emerging regulatory issuesCross-Business Initiatives:Lead cross-business regulatory council consisting of business regulatory heads, legal, government affairs, and AQRChair or co-chair council committees designed to execute objectives defined by the regulatory council, such as global conference, emerging issues, talent managementWork across businesses, government affairs, and legal to define, develop, and obtain consensus on Abbott regulatory positions on critical regulatory proposalsDevelop and maintain communication strategies for efficient and effective means of cross business information sharingStrategic Planning:Anticipate regulatory emerging issues and develop solutions to themIdentify need for new regulatory policies/processesDevelop solutions to address emerging regulatory issues with other members of management and stakeholdersDevelop corporate positions on regulatory risk-benefitCreate and develop positions and strategies based upon proposed regulatory requirementsInfluence:Identify for stakeholders new regulatory requirements to ensure company-wide complianceAdvance the organization’s position by participating and taking leadership roles in professional associations, industry and trade groups and appropriate standards organizationsAdvise management and stakeholders on regulatory issuesManage communication and negotiation with regulatory authorities and lobbying government leadersUtilize expert technical regulatory skills to influence regulators on complex issuesConsult with and advise businesses on regulatory issuesParticipate in the development of new regulations, guidelines and/or standards to promote scientific innovation balanced with appropriate safety concernsSupervisory / Management ResponsibilitiesProvides leadership without direct authority (i.e., project leader); includes 1 direct reportPosition Accountability / ScopeCorporate-wide strategies and programsExternal and internal regulatory advocacyRecognized as a key opinion leader and resource in regulatory affairsDevelops, communicates, and builds consensus for goals that are in alignment with the corporation.Provides leadership by communicating and providing guidance towards achieving cross-business and/or corporate objectives.Interfaces with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units.Leads multiple cross-business committees/teamsActs as a mentor to less-experienced staff internal and external to the department/division.Exercises judgment independently.Required QualificationsBachelor's degree7-10 years of experience in a regulated industry (e.g., medical device, pharmaceutical, nutritional/food products)Knowledge of how agency regulations and guidance are developedNegotiate internally and externally with regulatory agenciesWork with cross-functional teamsDemonstrated analytical, strategic-thinking, and problem-solving skillsCommunicate effectively verbally and in writing to diverse audiences and personnelWrite and edit regulatory documents; persuasive writingAbility to prepare and present written and oral reports and other presentations to internal and external audiences, including senior management and regulatory agenciesAble to juggle multiple and competing prioritiesPreferred QualificationsBachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fieldsAdvanced degree (MS in technical area, PhD, Law)7-10 years of experience in regulatory preferred, but may consider quality assurance, research and development/support, scientific affairs, operations, or related areaAPPLY NOWLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: 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 , on Facebook at and on Twitter @AbbottNews and @AbbottGlobalThe base pay for this position is $171,300.00 – $342,700.00In specific locations, the pay range may vary from the range posted.JOB FAMILY:Regulatory OperationsDIVISION:AQR Abbott Quality and RegulatoryLOCATION:United States > Abbott Park : AP52ADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 20 % of the TimeMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: is the Law link - Espanol: