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 109,000 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.
WHAT YOU'LL DO
We are recruiting for a Regulatory Project Manager to join our team located in Alameda, CA. This is an exciting opportunity to lead US submissions for New Product Introductions (such as Bio-wearables) and evolving regulatory areas such as the Digital space.
You will be fostering within the Regulatory department an environment of efficient and compliant business processes by partnering across business functions, contract manufacturers, and suppliers. You will take an active role identifying data needed and ensuring that it is effectively presented for FDA submission. Additionally, you and your team will work with a global regulatory team to ensure availability of documentation needed for registration worldwide.
Development of regional regulatory strategies in support of evolving applications and new technologies
SOP development and review in support of "next-gen" product offerings
Provide regulatory input to product lifecycle planning
Revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
Lead, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval, challenges, and risk.
Determine trade issues to anticipate regulatory obstacles.
Determine and communicate submission and approval requirements and plans.
Manage 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 applications under regulatory review.
Negotiate and interact with Regulatory authorities during the development and review process to ensure submission approval/success.
Monitor impact of changing regulations on submission strategies.
Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
Assist compliance with product post-marketing approval requirements
Review regulatory aspects of contracts in evolving segments of our business / product portfolio
Assist with label development and review for compliance before release
Review change controls to determine the level of change and consequent submission requirements, and advise stakeholders accordingly.
Provide regulatory input for product recalls and recall communications.
EDUCATION AND EXPERIENCE YOU'LL BRING
BS/BA degree (preferably in scientific or engineering related discipline) or combined relevant education and work experience in regulatory affairs.
6+ years of experience working in a regulated industry (i.e. pharma, healthcare, aerospace, defense, etc) in a similar role, including technical writing and technical submission experience.
Working knowledge of FDA Code of Federal Regulations as it applies to medical device manufacturing, including cGMP, ISO14971 , as well as complaint handling systems. Prior experience in the medical device industry and/or quality systems are required.
Proven track record of managing projects from initiation to completion in a timely manner.
Proficient in MS Office (Word, Excel, Outlook).
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Advanced level degree in a Biology, Chemistry, Life Sciences, Engineering, or other related technical field.
Premarket Notification 510(k) submissions experience - Medical device industry.
6+ months experience in a leadership/supervisory position.
Knowledge of FDA/International guidelines for drug/device safety reporting requirements.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
A fast-paced work environment where your contribution is essential to success
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
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:
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.
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