Regulatory Affairs Manager (Boston) Job at Katalyst CRO, Boston, MA

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  • Katalyst CRO
  • Boston, MA

Job Description

Join to apply for the Regulatory Affairs Manager role at Katalyst CRO

The Regulatory Affairs Manager will be responsible for drafting and filing documentation and submission materials for new and/or existing products to regulatory authorities in support of global product registrations.

Responsibilities

  • Draft and file documentation and submission materials for new and/or existing products to regulatory authorities in support of global product registrations.
  • Develop and implement regulatory strategies to achieve timely product approvals.
  • Prepare and submit regulatory documents to relevant regulatory agencies (e.g. US, EU, Health Canada).
  • Serve as primary point of contact with regulatory body, managing communications and addressing questions or concerns relative to product/project.
  • Monitor and interpret changes in regulatory guidelines and standards and assess their impact on the company.
  • Lead Regulatory communications to the broader organization on pertinent regulations updates.
  • Ensure ongoing compliance with regulatory requirements, including post-market surveillance.
  • Collaborate with R&D, PPM (product and project manager), QA, marketing, commercial, and other departments to integrate regulatory requirements into product development and commercialization.

Requirements

  • Bachelor's degree and/or Master's in Biology, Chemistry, bio-engineering, or related scientific area.
  • 5 years of medical device, IVD Regulatory Affairs experience, to include either 510(k) or PMA Notified Body (NB) submissions.
  • Preference for a former regulatory agency reviewer or staff (e.g., FDA submission reviewer).
  • Proficient in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
  • Experience in direct communication with regulatory agencies.
  • Regulatory review experience of promotional marketing materials, press releases, labeling, etc.
  • Strong oral and written communication skills, as well as the ability to provide scientific presentations.
  • Ability to compile data and summarize results.
  • Continuous improvement-minded, familiar with balancing Quality and the need for efficiency.
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Job Tags

Full time,

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