Associate Director, Regulatory Affairs
Abbott Park, IL
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.
ABOUT ABBOTT DIAGNOSTICS:
The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.
Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.
Our location in Lake Bluff, IL currently has an opportunity for a Regulatory Affairs Associate Director within our Transfusion Medicine Business Unit
WHAT YOU’LL DO
As a regulatory leader that provides direction and supervision to Regulatory Affairs staff , the function of a Regulatory Affairs Associate Director is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet worldwide regulatory requirements. 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 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.
- Directs staff of 3-5 regulatory professionals in implementing US and non-US regulatory strategy and preparing regulatory submissions for transfusion IVD assays and instrument systems (including software).
- Remains current on developments in field(s) of expertise, emerging 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 and professional associations.
- Develop and maintain rapport with world-wide regulators so that submission negotiations result in timely approvals as outlined in key commercialization and program strategies.
- Provide strategic guidance for product development, product support, and planning throughout the product lifecycle. Identify and present options for risk mitigation to decision makers
- Review of product, manufacturing and facility changes for compliance with applicable regulations (Change Control). Ensure compliance with product post marketing approval requirements.
- Regulatory SME for audits and inspections
- Identify need for new regulatory policies, processes and SOPs.
- 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.
EDUCATION AND EXPERIENCE YOU’LL BRING
- Bachelor’s Degree (or equivalent); 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.)
- 5-7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
- 5-7 years’ experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience.
Preferred / Ideal / Optional Experience, Education, etc.:
- Prior experience in IVD Blood Screening or Diagnostics products through knowledge of product development and/or regulatory affairs.
- Experience in US Biologics Submissions (BLA)
- 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. Ability to work effectively within a team in a fast-paced changing environment.
- Strong organizational, planning and follow-up skills.
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
- Pension Plan (exceptions may apply)
- 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: www.abbottbenefits.com
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.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The salary for this role is between:N/A
JOB FAMILY:Regulatory Operations
LOCATION:United States > Abbott Park : AP08/A
TRAVEL:Yes, 10 % of the Time
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), 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: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf