EU Senior Regulatory Affairs Specialist – Ref NHCL05

The primary role of the Senior Regulatory Affairs Specialist – Post Market is to assist in the running of the EU AR office by providing input into: the verification of compliance to the EU MDR for these manufacturers, liaising with EU regulators as requested and supporting EMEA regulatory strategy in line with agreed business requirements and timelines.




·       Responsibility for implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EUMDR 2017/745 and additional EMEA regulations as required.

·       Maintains an excellent understanding of the EMEA medical device regulations, identify and monitor legislative and regulatory activities within EMEA.

·       Serves as the technical EU expert for the post market phase of the total product lifecycle.

·       Ensuring that complaints and reports are communicated to the manufacturers the EU AR office presents.

·       Assist, advice and support the manufacturers with all post market activities.

·       Completes the EU AR obligations as outlined under Article 11 and 12 of EU MDR

·       Completes the EU AR obligations under MDD and per agreements.

·       Assess the manufacturers and devices the EU AR office presents for compliance to the EU MDR 2017/745.

·       Liaise with and respond to request for information and/or documentation from Competent Authorities, including any preventative or corrective action taken to eliminate or mitigate risks posed by devices.

·       Forward any requests for device samples from the competent authority to the manufacturer and assist in the provision of samples to the competent authority

·       Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.

·       Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.


Qualifications / Requirements:

·       Third level Qualification preferably in Science/Engineering or Law; 2 years’ experience in a regulated industry in a similar role desirable

·       Solid working knowledge of European regulatory environment including requirements of European Medical Devices Regulation (EU-MDR), Regulation (EU) 2017/745.

·       Knowledge of medical device quality standards/practises or similar regulated industry.

·       Strong strategic and analytical abilities, diplomacy, negotiation and excellent oral and written communications skills.

·       Proven ability to interact in a group environment, have strong interpersonal skills

·       Highly organised. A detail-oriented work style and the ability to handle multiple tasks.  

·       Proficient use of computers and use of Microsoft Office applications is required.

·       Willingness and availability to travel on company business.

·       High self-motivation.

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