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Senior Regulatory Specialist

Company: Integra LifeSciences
Location: Mansfield
Posted on: July 23, 2021

Job Description:


Under minimal supervision: Provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches, including submissions to transition devices from MDD to MDR compliance. He/she guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials and helps to define data and information needed for regulatory approvals in conjunction with cross-functional product development teams.

  

  • Ensures compliance with regulatory agency regulations and interpretations
  • Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines
  • Provides solutions to a variety of problems of moderate scope and complexity
  • Researches, collects data, and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates
  • Prepares regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance
  • Provides regulatory guidance to product development teams and responds to product information requests
  • Provide Regulatory Affairs support during internal and external audits
  • Assists in the development of best practices for Regulatory Affairs processes
  • Represents Regulatory Affairs on cross-functional project teams
  • Review and approve promotional material
  • Review change orders to ensure regulatory compliance
  • Support the transition, including leading submissions where required, for the transition of devices from MDD to MDR

Qualifications:

  • Degree in engineering or a science discipline required for this position. At least 5+ years' experience in an RA role, or equivalent medical device industry role (i.e.quality, engineering,etc.)
  • Excellent written, verbal communication and presentation skills.
  • Experience in the preparation and submission of US and EU regulatory filings.
  • Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products.
  • Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.                                                         
  • Consults with others to understand the benefits and risks associated with decision alternatives before making decisions.                                         
  • Provides support to complex projects and makes timely and effective decisions based on available information to execute project deliverables. Makes decisions with guidance in ambiguous or unclear situations.

Keywords: Integra LifeSciences, Boston , Senior Regulatory Specialist, Other , Mansfield, Massachusetts

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