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.

 

 

Responsibilities:

·       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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