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.