Abbott Regulatory Affairs Project Manager in Sunnyvale, California
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
Recognized as an expert and resource in regulatory affairs for domestic and international filings.
In addition, provides strategy for protocols and approves product testing protocols and reports, and product approval strategies under the direction fo the Regulatory Affairs Manager.
Supports project teams to obtain worldwide regulatory approval or clearance for AVD products.
Provides regulatory support to ensure compliance with all FDA and international regulatory requirements.
1) Serve as a mentor for Regulatory Affairs Coordinators, Associates, and Assistants.
2) Develop global regulatory strategies for new and modified products.
Participate in and provide input to project teams to assure that FDA and international product registrations and licensing applications (original submission and subsequent product enhancements.).
3) Prepare and submit PMA, IDE, 510(k) and international product registrations and licensing applications (original submission and subsequent product enhancements.).
4) Maintains a professional demeanor and technical expertise through familiarity with the literature, attendance at professional meetings and participation in team meetings.
5)Interpret new or existing regulatory requirements as they relate to AVD products and procedures.
Review and advise on labeling, product claims, marketing brochures, and other publications to ensure compliance with regulations.
Accountability / Scope / Budget
The nature and magnitude of the impact of this position's decisions and/or actions could potentially impact up to hundreds of thousands of dollars.
Earlier filings and/or approvals due to innovative strategy or excellence in execution can positively impact the company's revenues and corporate image.
Minimum Education & Experience
Bachelor's degree (preferably in medical, science or engineering related discipline) or equivalent combination of education and work experience is required. Preferably 8 years experience in the medical device industry, with 5 of those years related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class I, II, and III medical devices. Ability to work effectively on project teams. 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. Strong working knowledge of regulatory requirements for European community, Japan, Canada, and other countries.
ASJM Abbott St. Jude Medical
United States of America > Sunnyvale > S4494 : 645 Almanor Ave
Yes, 5 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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