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Senior Regulatory Affairs Manager

Company: Adaptive Biotechnologies
Location: New York
Posted on: August 7, 2022

Job Description:

We are powering the age of immune medicine-you can too. -At Adaptive, our goal is to harness the power of the adaptive immune system to make a difference in the lives of people living with many different diseases.As an Adapter, you will be surrounded by driven colleagues who think boldly and innovate fearlessly. You will experience meaningful challenges in your work and be fueled by the knowledge that you're making a difference in patient's lives.You belong here - come discover your story at Adaptive.Position OverviewThe Sr Regulatory Affairs Manager is responsible for supporting the development and operations team's compliance with FDA, CLIA, CAP, IVDR, and other global regulatory requirements. This position will be responsible for working cross-functionally to support key regulatory submissions as well as interfacing with regulatory authorities and key business partners.Key Responsibilities and Essential Functions

  • (Oversees or Manages) regulatory filings for new product introductions, and expanded indications, including providing guidance for requirements and authorizing/reviewing regulatory filing documentation
  • Oversees/Manages submissions in multiple ex-US jurisdictions, including the EU, APAC, Australia, and assume regulatory responsibility for compliance with IVDR.
  • Develops and executes change notification strategies for changes to registered products, both in the U.S. and globally
  • Contributes to agency communications in the event of notifiable nonconformances or adverse events
  • Owns and manages applicable regulatory processes and documents
  • Works with quality system process owners to identify and interpret applicable regulations and to mitigate any gaps
  • Reviews incoming project agreements and provide guidance for regulatory requirements for projects
  • Informs the cross functional team of any new or revised standards, expanded claims, recalls, adverse events, and impact on the IVD product and provide the appropriate data to the Project Lead to prepare Post Launch Monitoring Annual ReportPosition Requirements (Education, Experience, Other)Required
    • Bachelors + 12 years of related experience, or Masters + 8 years of related experience, or PhD + 5 years of related experience
    • Masters or PhD strongly preferred
    • 6+ years of regulatory experience in a medical device and/or diagnostics company involved with development, manufacturing, testing and distributing products or similar experiencePreferred
      • Experience managing regulatory filings with the FDA, EU, and other ex-US regulatory bodies is highly preferred.
      • Experience with U.S. and international IVD regulations
      • Broad knowledge of post market surveillance regulations, practices, and proceduresWhere permitted by applicable law, applicant must have received, or be willing to receive, a COVID-19 vaccine by date of hire to be considered for employment.Adaptive Biotechnologies is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. - -Equal Opportunity Employer/Veterans/DisabledInterview accommodations may be requested during initial interview scheduling communications.NOTE TO EMPLOYMENT AGENCIES: Adaptive Biotechnologies values our relationships with our Recruitment Partners and will only accept resumes from those partners who have active agreements with Adaptive. Adaptive Biotechnologies is not responsible for any fees related to resumes that are unsolicited or are received by any employee of Adaptive Biotechnologies who is not a member of the Human Resources team.

Keywords: Adaptive Biotechnologies, New York , Senior Regulatory Affairs Manager, Executive , New York, New York

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