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Senior Manager, Regulatory Affairs

Job Description:

The successful candidate is responsible for assisting in guiding regulatory affairs activities for the regulatory affairs department culminating in the preparation of relevant regulatory filings to FDA and global regulatory authorities, with a particular focus on companion diagnostics.  Responsibilities will include life-cycle management of select pipeline products that are both marketed and in development, maintenance of needed registrations and certifications, and alignment of regulatory strategy with corporate strategy in conjunction with senior management.

Essential Duties:

  • Guiding regulatory affairs staff to successfully participate in product design teams
  • Creates, evaluates and updates Regulatory Affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced, and guides staff in these activities
  • Reviews labeling/promotional/advertising materials, and other documents to ensure compliance, and guides staff in these activities
  • Maintains current knowledge of relevant regulations, including proposed and final rules.
  • Interprets RA policies and guidance and correctly apply them as regulatory activities, and guides staff in these activities
  • Development, management and execution of regulatory plans for large-scale projects, including companion diagnostics, and guides senior staff in these activities, as applicable


  • BA/BS degree is required. Preferred education/experience include bioengineering, biological, physical, clinical and regulatory sciences. Advanced degrees (MS, MBA, PhD., etc.) a plus
  • Previous in vitro diagnostic (IVD) nucleic acid experience and/or companion diagnostic (CDx) experience highly preferred
  • 6+ years of experience in Regulatory Affairs with FDA regulated products, minimum of 2 years of successful management experience
  • Previous experience with 510(k), IDE, and/or PMA submissions
  • Good knowledge of FDA QSR and ISO 13485 regulations
  • Experience in a Molecular Biology research environment
  • Strong intellectual capacity and curiosity, and ability to digest complex technical data
  • Certifications: RAC, CQA, CQM  preferred
  • Strong interpersonal skills with the ability to influence others in a positive and effective manner
  • Strong organizational skills and ability to support multiple projects
  • Proven ability to prepare regulatory submissions and interact with FDA to obtain and maintain product approvals, and equivalent in international markets
  • Proven ability to motivate and develop junior staff



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