at Abbott in Lake Forest, Illinois, United States
Job Description
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 115,000 colleagues serve people in more than 160 countries.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a high employer contribution
+ Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program, and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 the best place to work for diverse, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Lake Forest, IL or Charlottesville, VA, location in the Cardiometabolic and Informatics. Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges.
As the Associate Director Regulatory Affairs, you’ll have the chance to 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.
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 an 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.
+ Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
+ Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment.
+ 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, customers, contractors, and vendors.
Required Qualifications
+ Bachelor Degree (± 16 years) in a Technical discipline preferred OR an equivalent combination of education and work experience; OR
+ Minimum 12 years of related work experience
+ Demonstrated experience at a supervisory/managerial level.
+ Ability to travel approximately 15%, including internationally.
Preferred Qualifications
+ Prior experience in medical device thorough knowledge of clinical research and/or regulatory affairs preferred. Academic or in-house courses in leadership, training,
+ Prior experience in Software and or software as a medical device in a regulatory environment
+ Continuous Improvement (CI), cycle time improvement, etc., are preferred. RAPS certification, 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.
+ 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 a timely manner. Ability to plan strategically and work independently. Strong organizational, planning, and follow-up skills and ability to hold others accountable.
- 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 (http://www.abbottbenefits.com/pages/candidate.aspx)
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 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 corpjat@abbott.com
