Collins McNicholas

Regulatory Affairs Specialist

The regulatory affairs specialist 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 manufacturer and the local affiliates or regulatory authorities.

  

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 and FDA QSP 21CFR Part 820 as required.
  • Ensures a thorough understanding of the products they are assigned.
  • Communicates country/region specific regulatory requirements to the regulatory specialists/ managers.
  • Develop global regulatory strategies for medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), especially on high risk devices.
  • Advise other 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.
  • Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as required.
  • 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.
  • Ensures the biocompatibility requirements of the product are adequately addressed.
  • Communication of the clinical requirements for regulatory registrations for the product and working as part of a cross functional team to ensure that they are adequately addressed.
  • Communicates directly with notified bodies and other regulatory authorities to ensure product approvals are achieved in a timely manner.
  • 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 Manufacturer and the International local office and/or 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 functional units such as the SSC, tenders, customer quality and distribution.
  • Performs additional duties as assigned.
  • Can act as a designee for the RA manager if required.
  • Ensure that Code of Conduct is considered in all business matters carried out on behalf.

 

Qualifications / Requirements:

  • 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 and FDA QSP 21CFR Part 820 as required.
  • Knowledge of medical device quality standards/practises or similar regulated industry.
  • 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.

 

 

 

 

Firstname (required)

Surname (required)

Your Email (required)

Your mobile (required)

Upload CV (required)

Comment

In order to provide you with our services, we need to process certain personal information about you. We will only use your personal information to deliver the job-seeking or related services you have requested.

We seek your consent to store your data and provide you with the best possible service. If you have any questions regarding our legal obligations to you or your rights under the GDPR please refer to our privacy statement which clearly outlines all of your rights.

Related Articles

Biopharma Report

biopharma industry report biopharmaceuticals
Ensuring that the supply of qualified professionals is sufficient to meet demand will be the crucial step in successfully expanding the biopharma industry in Ireland. The EGFSN (Expert Group on Future Skills Needs) estimates that 5,000 additional staff will be employed in biologics manufacturing by 2020. The number of professionals employed in the production of traditional […]
Read More

Why Inma Aguilera chose Galway for her career

Inma Aguilera, Manufacturing Process Development Engineer, Creganna Medical, Galway Beautiful scenery, a fifteen-minute commute and the opportunity to grow her career. Why Inma Aguilera is loving life in Galway! The West of Ireland is a great place for engineers to further their careers because there are so many large companies where you can grow and progress your […]
Read More