Director, Regulatory Affairs

1 month ago

Lake Forest, United States Abbott Laboratories Full time
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. Youâll 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 Savestudent debt program and FreeUeducation benefit - an affordable and convenient path to getting a bachelorâs 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

MAIN PURPOSE OF ROLE

This position has primary management responsibility directly or through lower management levels for the preparation and submission of product approval applications. Works with regulatory agencies to obtain timely approvals of all products. Recommends, interprets and implements companywide policies and procedures to accomplish assignments and resolves a broad range of issues and problems. Ensures employee compliance with such policies, practices and procedures and is responsible for continuous process improvement. Assures that quality of services meets internal and external customer requirements

MAIN RESPONSIBILITIES

â¢Sets and executes effective RA 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.

â¢Provides guidance on regulatory requirements and strategies to product development project teams and MCSO.

â¢Maintains expert working knowledge of laws, regulations may impact company operations and decision making; communicates such knowledge to all internal stakeholders.  Identifies risks inform how to reduce risk of non-compliance with current and pending regional product regulatory guidelines, rules, and regulations.

â¢Consults with and provides advice to senior management of the division on strategies and plans for regulatory product approvals. Work closely with MCSO, R&D, Quality, and Marketing teams to align regulatory activities with business objectives.

â¢Directs staff in implementing regulatory strategy and preparing regulatory submissions.

â¢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.

â¢Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.

â¢Performs related functions and responsibilities, on occasion, as assigned.

â¢Supports all business segment initiatives as identified by divisional management and in support of RA strategy for NPI  and other regulatory requirements.

â¢Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment.

â¢Serves as an influential spokesperson with FDA staff , including leading meetings and preparations to facilitate expedited approval of original applications and supplements.

â¢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 communications and collaboration with all levels of employees.

QUALIFICATIONSEducation
  • Bachelors Degree (± 16 years)In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields are preferred or an equivalent combination of education and work experience
  • Masters Degree (± 18 years)Preferred
  • Doctorate Degree (± 19 years) Preferred

Experience/Background
  • Minimum 10 years Progressive work experience in regulatory affairs or a related discipline in the medical device field.
  • Experience in a regulated industry (e.g., diagnostics, medical products, ). 10+ years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
  • Minimum five years of demonstrated experience at a supervisory/managerial level.
  • An advanced credential in a relevant discipline/concentration desired.
  • Prior experience in medical device and thorough knowledge of clinical research and/or regulatory affairs preferred
  • Experience working in a broader enterprise/cross division business unit model preferred.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
  • Submission/registration types and requirements
  • Ability to work effectively within a team in a fast-paced changing environment.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Ability to multi-task, prioritize and meet deadlines in timely manner.
  • Ability to plan strategically and work independently.
  • Strong organizational, planning, and follow-up skills and ability to hold others accountable. 
  • Ability to travel approximately 15-25%, including internationally.

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.



The base pay for this position is $162,000.00 â $324,000.00. In specific locations, the pay range may vary from the range posted.

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