Regulatory Affairs Manager – Canada & Latin America – Diabetes Care (on-site)

Abbott

  • Alameda, CA
  • $112,000-224,000 per year
  • Permanent
  • Full-time
  • 2 days ago
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 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 of.
  • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • An excellent retirement savings plan with high employer contribution
  • Tuition reimbursement, the
student debt program and 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.
At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.The OpportunityThis Regulatory Affairs Manager will work on-site in Alameda, CA for our Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.As the Regulatory Affairs Manager, you will combine your knowledge of scientific, legal and business issues to ensure products, which are developed, manufactured or distributed by Abbott Diabetes Care, meet the required legislation in Canada and Latin America. Additionally, the Manager will have department/group/site level influence and is generally recognized as an expert and resource within the department, leading successful regulatory submissions and interactions with regulatory agencies while working with in-country affiliates. The Regulatory Affairs Manager may analyze broad scope implications of changing regulations and guidance as well as identify data needed, obtain this data and ensure that it is effectively presented for the registration of products in Canada and Latin America. In addition, this Manager will develop and coach a team of regulatory professionals.What You’ll Work On
  • Develop new regulatory policies, processes and SOPs and train key personnel on them. Evaluate regulatory risks of division policies, processes, procedures. Recruit, develop and manage regulatory professionals.
  • Provide regulatory input to product lifecycle planning. Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management. Provide strategic input and technical guidance on regulatory requirements to development teams to support registration in Canada and Latin America, working with in-country affiliates.
  • Evaluate proposed design and manufacturing changes for regulatory impact and implement any required regulatory action based on discussions with in-country affiliates
  • Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes in Canada and Latin America, working with in-country affiliates.
  • Manage and coach a team; Set goals which align to department plans and monitor the execution of goals through mentoring and training
  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle in Canada and Latin America and develop solutions with other members of regulatory and related teams and in-country affiliates. Monitor trade association positions for impact on company products.
  • Assess the acceptability of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submission to authorities in Canada and Latin America, working with in-country affiliates.
  • Interact, answer questions and negotiate with regulatory agencies during the submission review process to obtain submission approval, working with in-country affiliates
  • Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions.
  • Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
  • Provide regulatory support for internal and external audits
Required Qualifications
  • Bachelor’s Degree or an equivalent combination of education and experience
  • 4-5 years’ experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience.
Preferred Qualifications
  • Bachelor’s degree in Biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology math, engineering, or medical fields.
  • Advanced degree in Engineering, Sciences, or related discipline
  • Previous experience with Class III IDE submissions and/or PMA submissions or EU Technical Files or Canada Class III & IV License Applications
  • Experience collaborating with cross-functional teams in a geographically diverse, matrixed organization
  • 8+ years of experience related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class II, and III medical devices or EU Technical Files or Canada Class III & IV License Applications
  • Ability to work effectively on project teams and lead functional groups in the development of relevant data to complete a regulatory submission.
  • Must be able to juggle multiple and competing priorities.
  • Strong written, verbal, presentation, and organizational skills.
  • Scientific writing experience is required.
  • Working knowledge of QSR, ISO, and EN standards.
  • Communicate effectively verbally and in writing
  • Negotiate internally and externally with regulatory agencies
  • Think analytically with good problem-solving skills
  • Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues
Learn 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.Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.The base pay for this position is $112,000.00 – $224,000.00. In specific locations, the pay range may vary from the range posted.

Abbott