- 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.