Regulatory Affairs & Communications Specialist

Requisition ID
2017-3033
Job Location(s)
Limerick Ireland
Languages Required
English
Company
Cook Ireland
Position Type
Full Time
Category
Regulatory Affairs
Education
Bachelor's Degree

Overview

The regulatory affairs specialist EMEA and Regulatory Communications helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets, serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities and assists in assessing complaints for Regulatory Reporting, this includes Adverse Event Reporting (MDR, Vigilance, etc.) and associated correspondence to applicable Regulatory bodies.

 

Reporting to: Regulatory Affairs Manager  

 

 

Find out more about Cook Medical here

Responsibilities

  • Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned.
  • Communicates country/region specific regulatory requirements to the regulatory specialists/ managers.
  • Responsibility for structuring and managing technical files.
  • Responsibility for implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820 as required.
  • Plans and prepares regulatory submissions in the EMEA, and other markets as appropriate for new products, product changes and re-registrations as required.
  • Responsibility for registration of all Class I devices with the Irish Medicines Board.
  • Maintains registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.
  • Communicates directly with notified bodies and other regulatory authorities to ensure product approvals are achieved in a timely manner.
  • Responsibility for handling regulatory affairs related queries.
  • Responsibility for ensuring that device labelling is correct and that they meet regulatory requirements.
  • Develop global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), especially on high risk devices.
  • Advise other Cook functional units (engineering, marketing, operations, quality etc) of the requirements in each target market.
  • Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
  • Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner.
  • Provides support to currently marketed products as necessary including input on change requests, etc.
  • Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
  • Provides regulatory support to Cook functional units such as the SSC, tenders, customer quality and distribution.
  • As part of Regulatory Communications Specialist role - the following apply:

o Assess complaints from Cook global distribution centres for adequate information to determine if event meets Regulatory Reporting requirements.

o Utilize appropriate complaint software systems for processing complaints to/from distribution centres and QE Investigation functions.

o Generate appropriate regulatory reports based on assessment.

o Liaise effectively with regulators on all issues with regard to regulatory reporting.

o Ensuring that confirmed reportable events are escalated to the appropriate personnel in a timely manner.

o Communicate with other Cook Companies globally as necessary for reporting.

o Generate responses to inquiries on AE reports from various global regulatory authorities.

o Generate various reports, including but not limited to, Regulatory requests, Marketing requests, Engineering requests.

o Assist in coordination of Recall administration activities between manufacturer and distribution centre.

o Reviewing and approving reports and responses as necessary.

o Close out of complaints as necessary.

  • Performs additional duties as assigned.
  • Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

Qualifications

  • Third level Qualification in Science/Engineering, at least 5 years experience in a regulated industry in a similar role.
  • Thorough knowledge of the EU, MDD requirements.
  • Knowledge of requirements in GHTF countries.
  • Desirable to have knowledge of requirements in other jurisdictions.
  • Knowledge of medical device quality standards/practises or similar regulated industry.
  • Good communication and inter-personal skills.
  • Proven problem-solving skills.
  • Good computer skills including knowledge of Microsoft ® Office.
  • Proven organisational skills.
  • High self-motivation.
  • Approved External Auditor.
  • Willingness and availability to travel on company business.

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