Post Market Surveillance Specialist 1

Job title:

Post Market Surveillance Specialist 1

Company

Cook Medical

Job description

OverviewThe Post Market Surveillance Specialist 1 assists in the implementation of regulatory strategies, performs activities associated with the EU Authorised representative office. The successful candidate serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities.Responsibilities

• Obtains and maintains an understanding EMEA medical device regulations for specific jurisdictions as assigned such as regulatory requirements in accordance with (EN)ISO13485, MDD 93/42/EEC and EUMDR 2017/745 and additional EMEA regulations (including the UK and Switzerland) as required, become proficient / knowledgeable in EMEA medical device regulations.
• Develop a thorough understanding of the medical devices they are assigned.
• 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.
• Ensures processes and procedures are put in place and maintained as part of the 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/ mandates are in place between the EU AR and Cook manufacturers that the EU AR represents.
• 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. Provides Assistance to Cook UK (UKRP) and the Swiss Representative.
• 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.
• Provides support for regulatory audits
• 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.
• Acts as a regulatory affairs change analyst
• Assist in post market responsibilities as required with the following duties:

• Liaise effectively with regulators on all issues with regard to regulatory reporting and field safety corrective action.
• Ensuring that confirmed reportable events are escalated to the appropriate personnel in a timely manner.
• Communicate with other Cook Companies globally as necessary for reporting.
• Generate various reports, including but not limited to, Regulatory requests, Marketing requests, Engineering requests.
• Assist in coordination of Recall administration activities between manufacturer and distribution centre.
• Assessment of manufacturers EU AR represents for compliance to EU MDR 2017/745.
• Forward any requests for device samples/ documentation from the competent authority to the manufacturer and assist in the provision of samples/ documentation to the competent authority.
• Performs additional duties as assigned.

Qualifications

• 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.

About Cook LimerickCook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook’s products for global markets.Regulatory in LimerickOur RA team in Limerick are responsible for global regulation in over 60 countries, managing pre- & post- market regulation for all product classifications and novel devices across EMEA, AMER and APAC.Working cross functionally with clinical, quality and engineering during the design process and throughout the device lifecycle, RA are involved in a broad range of activities including marketing authorization and submissions, vigilance and adverse event reporting and clinical evaluation. Our Regulatory Affairs team are central to holding Cook to the highest standards because everything we do has an impact on someone’s life.Our employee benefits include:

• Hybrid Work Model
• Company sponsored Defined Contribution pension scheme
• Medical Health Insurance cover for you and your immediate family
• Life Assurance and Income Protection cover
• Educational Assistance
• Performance related Bonus
• Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks
• Fully equipped gym on site
• 39-hour week with flexible start & finish times
• Paid time off to participate in volunteer activities
• Free parking

• Subsidised restaurant
• Sports & Social club

#LI-Hybrid

Expected salary

Location

Limerick

Job date

Fri, 26 Apr 2024 01:37:33 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (un-jobs.net) you saw this job posting.