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 103,000 colleagues serve people in more than 160 countries.
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.
Our location in Alameda, CA currently has an opportunity for a Regulatory Affairs Senior Specialist that is focused on exciting new product registrations and existing products maintenance from a Canada and Latin America perspective, and also working with commercial on advertising & promotional review (ad promo).
WHAT YOU'LL DO:
As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products in Canada and Latin America. The individual may prepare and submit documentation needed for registration or may oversee such preparation. This is a broad scoped position with strong opportunity for growth and career development.
- Assist in SOP development and review.
- Provide regulatory input to product lifecycle planning.
- Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
- Assist in the development of regional regulatory strategy.
- Understand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval.
- Determine trade issues to anticipate regulatory obstacles.
- Determine and communicate submission and approval requirements.
- Participate in risk benefit analysis for regulatory compliance.
- Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
- Compile, prepare, review and submit regulatory submission to authorities.
- Monitor impact of changing regulations on submission strategies.
- Monitor applications under regulatory review.
- Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
- Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
- Assist compliance with product post marketing approval requirements.
- Review regulatory aspects of contracts.
- Assist with label development and review for compliance before release.
- Submit and review change controls to determine the level of change and consequent submission requirements.
- Provide regulatory input for product recalls and recall communications.
EDUCATION AND EXPERIENCE YOU'LL BRING:
Three (3) years of regulatory affairs experience within medical devices in Canada and Latin America. Bachelor’s degree (or equivalent).
Experience with class III PMA products or CE marked product is preferred. Diagnostics and pharmaceuticals regulatory affairs experience is a possibility if the candidate has a strong background in ad promo.