1+ months
2018-03-152018-05-02

Regulatory Affairs Project Manager- Ad/Promo

Abbott
Los Angeles, CA

At Abbott, we're committed to helping people live their 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, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Provide regulatory affairs project management for various areas, to include 510(k), PMA, IDE, PreIDE, label/advertising/promotional review, and other regulatory compliance activities. In collaboration with the Regulatory leadership, develop and implement regulatory strategies that will ensure earliest possible introduction of product(s) into domestic and international markets.  Coordinate preparation of well-organized, complete and scientifically sound regulatory submissions.  Interface directly with various regulatory agencies, as required, to facilitate the review and approval of regulatory applications.   Exercise judgement within generally defined practices and departmental standard operating procedures.  Accountable for budgets and schedules.  Develop and maintain strong and effective relations with internal/external personnel.

Main Responsibilities

o    Mentor RA associates to ensure regulatory requirements are identified and addressed in product development teams.

o    Keep abreast of regulatory requirements in the US and countries where ADC intends to offer product for sale.

o    Work with the Regulatory leadership to prepare regulatory plan/strategy for product introductions.

o    Manage the preparation of registration documents as required for international markets.

o    Ensure that submissions are complete, properly formatted, and comply with applicable regulatory requirements.

o    Make certain that appropriate documentation is maintained to record regulatory decisions made in design and development activities.

o    Provide expert advice on regulatory requirements for advertising and promotion labeling of ADC products.

o    Additional Responsibilities:

o    Provide input and comment on regulations and standards which may affect ADC products.

o    Review and make recommendations on policies and procedures that impact regulatory activities.

o    Recruit, develop and manage regulatory professions.

Qualifications

o    BS/BA degree required, preferably in scientific or engineering related disciplines or combined relevant years of education and work experience in regulatory affairs. Advanced degree or additional professional training in regulatory affairs (RA) desired.  

o    Require a minimum of 5 years RA experience, including oversight of submissions for new products and product changes in the health care industry and/or medical devices industry plus at least 1 years in an RA project management role.  

o    Some of the required 3 years overall RA experience can be substituted with experience in a scientific/technical role in the health care industry and/or medical devices industry plus.

o    Must have well developed written, oral, interpersonal and negotiation skills. Leadership competency including organizational development and project management skills.
Job Family: Regulatory Operations
Division: ASJM Abbott St. Jude Medical
Travel: Yes, 15 % of the Time
Medical Surveillance: No
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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Regulatory Affairs Project Manager- Ad/Promo

Abbott
Los Angeles, CA

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Regulatory Affairs Project Manager- Ad/Promo

Abbott
Los Angeles, CA
US

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