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Project Manager, Regulatory Affairs

Company: Abbott Laboratories
Location: Santa Clara
Posted on: January 15, 2022

Job Description:

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.Project Manager, Regulatory Affairs - Santa Clara, CA / St. Paul, MN / Burlington, MA ABOUT ABBOTTOur business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of STRUCTURAL HEART disease.-- - We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care. WHAT YOU'LL DO-- - We are recruiting for a Regulatory Affairs Project Manager to join our team in the Santa Clara, CA, St. Paul, MN, or Burlington, MA. -- -In this role, you will combine knowledge of scientific, regulatory and business issues to enable products to meet required legislation. You will be responsible for compiling regulatory submissions and ensure data is effectively presented for the registration of products worldwide. Responsibilities:Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on regulatory requirements for Class III and Class II medical devicesAssess the acceptability of documentation for Class III and Class II medical device submissions and effectively communicate regulatory guidanceCompile, prepare, review and submit Class III and Class II medical device submissions to regulatory agenciesInteract, answer questions and negotiate with regulatory agencies during the submission review process to obtain submission approvalEvaluate proposed design and manufacturing changes for regulatory impact and implement any required regulatory actionUtilize technical regulatory skills to propose strategies on complex issuesMonitor regulatory landscape for impact to company products and help to develop solutions to regulatory obstacles, with other members of regulatory and related teamsEnsure compliance with product post marketing approval requirementsReview product labeling and promotional material to ensure compliance with relevant regulatory requirements.Help to develop regulatory strategy for Class III and Class II medical devices, with other regulatory team membersProvide regulatory support for internal and external audits EDUCATION AND EXPERIENCE YOU'LL BRING-- -Required:-- -Bachelor's Degree in Engineering, Sciences, or related discipline8+ years of experience in the medical device industry, including experience with Class II or Class III medical device submissions to regulatory agenciesProficient with MS Office (Word, Excel, Outlook)Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization Preferred:Advanced degree in Engineering, Sciences, or related disciplinePrevious experience with Class III IDE submissions and/or PMA submissionsExperience with Canada, EU and other international medical device regulations and submissionsExperience collaborating with cross-functional teams in a geographically diverse, matrixed organization 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-- -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.-- - Connect with us at , on Facebook at /Abbott and on Twitter @AbbottNews and @AbbottGlobal

Keywords: Abbott Laboratories, Santa Clara , Project Manager, Regulatory Affairs, Executive , Santa Clara, California

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