Regulatory Affairs Manager

Organization
Personal Genome Diagnostics, Inc.
Job Location
2809 Boston St #503
Baltimore, MD 21224
Job Description

Personal Genome Diagnostics (PGDx) is seeking a Regulatory Affairs Manager to help in the fight against cancer by identifying and implementing process improvements and updates to regulatory department SOPs. As the Regulatory Affairs Manger, you will assist in reviewing new regulations for implications for the company and recommending a strategy to achieve compliance with requirements.

Key Responsibilities Include: 

  • Write submission documents for FDA, Health Canada, Notified Bodies, and other regulatory agencies. Develop responses to questions or deficiency letters from regulatory agencies.
  • Proactively partner with R&D, Marketing and other groups to confirm the regulatory requirements necessary to place products on international and domestic markets. Develop and approve appropriate technical documents for regulatory submissions in support of the development project.
  • Develop and maintain Technical Files for CE marking.
  • Assess regulatory impact of post-market changes on labeling, design, materials, or manufacturing process.
  • Participate as a member of new product development teams to provide regulatory support to the project.
  • Identify and implement process improvements and updates to regulatory department SOPs.
  • Review new regulations for implications for the company and recommend strategy to achieve compliance with requirements.
  • Participate in ensuring a global regulatory team approach.
Requirements
  • Required 3-4 years in regulatory affairs within the medical device industry (IVD experience highly preferred).
  • Preferred experience in ex-US regulatory submissions.
  • Preferred experience in writing/maintaining CE Technical Files.
  • Minimum Bachelor’s degree in a technical discipline required; Master’s Degree in a technical discipline preferred.
  • Regulatory Affairs Certification (RAC) preferred.
  • Must be able to work independently and efficiently to complete multiple projects within deadline.
About Our Organization

Empowering the Fight Against Cancer by Unlocking Actionable Information from the Genome. We are committed to developing a portfolio of regulated tissue-based and liquid biopsy genomic products for laboratories worldwide.

PGDx is located in Baltimore MD and offers competitive salaries, vacation/holiday pay, medical benefits and a stimulating work environment.

 

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