Job Information
Abbott Associate Director, Regulatory Affairs in Santa Clara, California
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.
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 (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 a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This Associate Director, Regulatory Affairs, will work in the Abbott Rapid Diagnostics Division. The location is in Lake Forest, Illinois or Sylmar, California. This role is on site and is not considered hybrid. The main responsibility of this role is to combine knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured or distributed to meet required regulations. You will also provide regulatory direction on new product design and development activities to cross-functional teams and ensure that the development strategy supports submission activities to meet program objectives and timelines.
What You’ll Work On
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
The person hired in this role will have department level influence and is generally recognized as an expert resource both within Abbott and externally.
The person hired has an opportunity to influence changing regulations and guidance, interface with regulatory agencies and trade associations.
Provide strategic guidance for product development and planning throughout the product lifecycle.
Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
Develop global regulatory strategies and update based upon regulatory changes.
Utilize technical regulatory skills to propose strategies on complex issues.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
Create project plans and timelines.
Write and edit technical documents.
Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions.
Negotiate with regulatory authorities during the development and review process to ensure submission clearance/approval.
Review and approve labeling to ensure compliance.
Provide strategic input and technical guidance on regulatory authority queries.
Monitor emerging issues and identify solutions.
Identify need for new regulatory policies, processes and SOPs and develop them.
Conduct regulatory due diligence for potential and new acquisitions and advise management.
Participate in trade associations.
Perform submission risk assessment and provide guidance for how risk can be mitigated or lowered.
Review and approve advertising and promotional materials.
Ensure that data are identified, obtained and effectively presented for the registration of products worldwide.
Required Qualifications
Bachelor's degree
5-7 or more years’ experience in a regulated industry (e.g., medical products, in vitro diagnostics).
5-7 or more 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, math, engineering, or medical fields.
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.)
Previous experience with 510k and CLIA waiver submissions.
Previous experience working with hematology devices.
Ability to work effectively on cross-functional teams.
Must be able to juggle multiple and competing priorities.
Strong written, verbal, presentation, and organizational skills.
Experience with FDA QSR.
Experience working within Abbott is preferred.
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.
The base pay for this position is $144,100.00 – $288,300.00. In specific locations, the pay range may vary from the range posted.
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