Regulatory Affairs Specialist - Product Innovation

Regulatory Affairs Specialist - Product Innovation

Cook Medical

Limerick, Ireland

Overview

The Regulatory Affairs Specialist (Product Innovation) helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The Regulatory Affairs Specialist serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities.

Reporting to: Regulatory Affairs Manager

Responsibilities

  • Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned such as regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required;
  • Ensure a thorough understanding of the products assigned;
  • Support the global Regulatory function in the transfer of NPI products to Cook Ireland;
  • Provide critical scientific review and regulatory-based guidance through all phases of a project;
  • Provide direction in the development of non-clinical study plans to support global regulatory strategy and submissions;
  • Provide critical review of non-clinical reports for accuracy and consistency with regulator’s expectations;
  • Communicate country/region specific regulatory requirements to the regulatory specialists/ managers;
  • Develop global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personnel (as applicable), especially on high risk devices;
  • Advise other Cook functional units (engineering, marketing, operations, quality etc) of the requirements in each target market;
  • Ensure the outputs from the individual functional units meet the applicable regulatory requirements;
  • Plan and prepare regulatory submissions for specific target markets for new products, product changes and re-registrations as required;
  • Maintain registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability;
  • Communicate directly with notified bodies and other regulatory authorities to ensure product approvals are achieved in a timely manner;
  • Coordinate multiple projects at one time and provide regular reports to regulatory management and others as required;
  • Provide support to currently marketed products as necessary including input on change requests, etc.;
  • Maintain and organise appropriate regulatory records to demonstrate compliance with applicable regulations.

Qualifications

  • Third level Qualification preferably in Science/Engineering; 5 years experience in a regulated industry in a similar role desirable;
  • Ideally have knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required;
  • Knowledge of medical device quality standards/practises or similar regulated industry;
  • Excellent communication and inter-personal skills;
  • Proven problem-solving skills;
  • Good computer skills including knowledge of Microsoft® Office;
  • Proven organisational skills;
  • High self-motivation;
  • Willingness and availability to travel on company business as required.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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