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Sr. Regulatory Affairs Specialist

Apply Now Job ID R-347427 Date posted 09/13/2019

Job Description Summary

Job Description

Manage regulatory projects to ensure timely introduction of new products subject to medical device and combination product regulations in U.S. and global regions. Provide technical and administrative regulatory support to marketed products and ensure company’s regulatory compliance status.

**This position doesnotoffer relocation assistance**

Essential Duties and Position Responsibilities

  • Prepare and submit applications to the FDA for clinical testing and marketing of new/modified medical devices (e.g., 510(k)’s, IDE’s, PMA’s, PMA supplemental applications)
  • Support in determination of the appropriate regulatory submission requirements and strategies for new or modified products.  Prepare required documentation as needed (e.g., No 510(k) Rationales, international change notifications).
  • Coordinate review of FDA submissions and test protocols with Corporate Regulatory, Medical and Legal Departments, and respond to any questions posed by these departments or the FDA.
  • Prepare application documentation for international marketing approvals (i.e. CE Mark Technical files and Dossiers, JSTD, International Dossier).
  • Assist Product Development and Quality Assurance in planning pre-clinical studies and bench testing that will ultimately be used in regulatory submissions.
  • Assist in the review of proposals for clinical design validations, clinical field trials and customer preference tests.
  • Represent regulatory affairs on product development teams to provide direction with respect to regulatory/clinical requirements and strategy.
  • Assist in development of new product instructions for use/promotional material.  Review product labeling for compliance with medical device regulations and Division/Corporate Policies.
  • Provide marketed product regulatory support for change management activities, product registrations, and business improvement activities.
  • Support due diligence and business integration activities as assigned.
  • Support the development and implementation of Davol and Bard regulatory processes, procedures, and standards as assigned.

Qualifications, Knowledge, and Skills Required:

  • B.S. or equivalent with emphasis on Life Sciences.
  • Professional certifications and advanced degree preferred.
  • Knowledge and experience (5+ years) with regulatory requirements for medical devices and / or combination products (IDE’s, PMA’s ,510(k)’s, CE mark technical files and design dossiers).
  • Good oral and written communications skills - analytical thinking and technical writing; ability to work on cross-functional teams; ability to manage several parallel deliverables.
  • Working knowledge of statistics and electronic documentation and information systems.
  • Ability and desire to travel as needed.

#LI-TECH

Primary Work Location

USA RI - Warwick

Additional Locations

Work Shift

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