Regulatory Affairs Associate - Alameda, California | CareerCircle
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Regulatory Affairs Associate

Actalent

02/22/2022

Posting ID: JP-002663601

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Alameda, California
Full Time
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Hiring a Regulatory Affairs Associate at a great medical device company in Alameda, CA!

Description:

  • Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
  • Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
  • Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices.
  • May require an advanced degree and 5-8 years of direct experience in the field. Recent experience with Class III implantable medical devices;
  • Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.
  • Relies on extensive experience and judgment to plan and accomplish goals.
  • Performs a variety of tasks.
  • May lead and direct the work of others.
  • A wide degree of creativity and latitude is expected.
  • Typically reports to a manager or head of a unit/department.

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Contact Information

Recruiter: Jean Chambers

Phone: (410) 579-3072

Email: jchambers@careercircle.com

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