The regulatory affairs associate assists in the implementation of regulatory strategies, performs activities associated with the EU Authorised representative office. The regulatory affairs associate serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities.
Reporting to: CMEU Regulatory Affairs Manager
Find out more about Cook Medical here
- Obtains and maintains an understanding EMEA medical device regulations for specific jurisdictions as assigned such as regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and EUMDR 2017/745 and additional EMEA regulations as required, become proficient / knowledgeable in EMEA medical device regulations.
- Develop a thorough understanding of the medical devices they are assigned.
- Assist in the implementation of global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), on all classes of devices.
- Work with the global project manager EU MDR and other global and local team members to successful implement the requirements of the EU MDR at the office of the EU Authorised Rep CMEU and/ or sister Cook companies as required.
- Work with the EU MDR implementation team to ensure processes and procedures are put in place as part of the CMEU QMS to carry out the role of EU AR as per Article 11 of EU MDR.
- Maintain close contact and links with relevant Cook manufacturing sites and ensure contracts are in place between the EU AR and Cook manufacturers that the EU AR represents.
- Maintains registration information (license numbers, expiration dates, regulatory logs for annual reports, filing / printing of regulatory submissions, correspondence etc).
- Perform and maintain EMEA regulatory restrictions as required.
- Provides regulatory support to Cook functional units such as the CMEU acting as importer and distributor, EUSC, tenders, customer quality and distribution channel management.
- Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
- Working with other functional units / departments in assessing changes to medical devices, determination of regulatory impact and communication to regulatory management.
- Assistance in procedure updates where required; circulation of change requests
- Organizing documentation notarization, legalization / apostille with notary, Department of Foreign Affairs and relevant Embassies as appropriate for EMEA regulatory tasks.
- Provides support to currently marketed products as necessary including input on change requests, PMS, Regulatory Reporting etc.
- Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
- Assist in post market responsibilities as required with the following duties:
- o Liaise effectively with regulators on all issues with regard to regulatory reporting and field safety corrective action.
- 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 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 Assessment of manufacturers EU AR represents for compliance to EU MDR 2017/745.
- o Forward any requests for device samples from the competent authority to the manufacturer and assist in the provision of samples to the competent authority.
- Performs additional duties as assigned.
- Third level Qualification in Science/Engineering or law is desirable.
- At least 1 year experience in a regulated industry preferable but not essential.
- Basic knowledge / interest in Regulatory Affairs.
- Basic 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.
- Willingness to travel on company business when required.
To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.