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.
The EU Authorised Representative (EU AR) Office will represent Cook Medical to all regulators within the EMEA. They will act on behalf of Cook Medical manufacturers outside the EU in accordance with EU-MDR - (EU) 2017/745. They will also support CMEU in a regulatory capacity.
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. Update processes and procedures as appropriate and report their potential impact on the company to local, global leadership, manufacturing entities and functional units as necessary.
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 postmarket activities including Vigilance Adverse Event Reporting, field safety corrective action, Postmarket reviews and reports and associated correspondence to applicable Regulatory bodies as requested- designee peer review of same when required.
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.
Communicates status of projects / submissions directly to RA Management and other stakeholders as required.
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.
Works with senior management to allocate sufficient resources to complete projects in a timely manner.
Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
Ensures a thorough understanding of the products the EU AR are representing from the relevant Cook Manufacturer.
Coordinates multiple projects at one time and provides regular reports to regulatory management and others 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.
Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.
Performs additional duties as assigned.
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. Incumbent must have the ability to present facts and recommendations effectively in oral and written form.
Proven ability to interact in a group environment, have strong interpersonal skills and the ability to establish and maintain effective relationships with all stakeholders. Must be a strategic team builder with good business acumen, combined with hands-on approach.
Highly organised. A detail-oriented work style and the ability to handle multiple tasks. Must be able to work under pressure and meet deadlines.
Proficient use of computers and use of Microsoft Office applications is required. Additional experience with databases and report writing is a plus.
Willingness and availability to travel on company business.