Regulatory Affairs Specialist 2

Cook Medical Incorporated; Limerick; On-site; EUR 60,000 - 85,000; Full time

Job summary

Cook Medical Incorporated is seeking a Regulatory Affairs Specialist 2 in Ireland to help develop regulatory strategies for medical devices and coordinate submissions across target markets.

You will act as a liaison between Cook's manufacturing, local affiliates, distribution partners and regulatory authorities, ensuring timely registrations, compliance with ISO, EU and FDA standards, and ongoing post-market regulatory support across multiple projects.

Qualifications

• Third level qualification in Science/Engineering; 3–5 years in a regulated industry desirable.
• Knowledge of ISO, EU and FDA medical device standards required.
• Knowledge of medical device quality standards or similar regulated industry.

Responsibilities

• Understands products and regions assigned; communicates regulatory requirements to RA team.
• Develops global regulatory strategies for medical devices with other teams.
• Prepares regulatory submissions for target markets for new products or changes.
• Maintains registration information and ensures timely re-registrations.
• Coordinates with regulatory authorities, affiliates, partners to achieve approvals.
• Provides regulatory support to Cook functional units and handles change requests.

Skills

Regulatory affairs

Communication skills

Problem solving

Microsoft Office

Education

Science/Engineering degree

Job description

Overview

The Regulatory Affairs Specialist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates, distribution partners or regulatory authorities.

Find out more about Cook Medical here

Responsibilities

• Ensures a thorough understanding of the products and/or regions they are assigned.
• Communicates country/region specific regulatory requirements of the regions they are assigned to the RA team.
• Develop global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), especially on high risk devices.
• Advise other Cook functional units (engineering, marketing, operations, quality, biocompatibility etc) of the requirements in each target market.
• Ensure the outputs from the individual functional units meet the applicable regulatory requirements.
• Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as required.
• Maintains registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.
• Communication of the clinical requirements for regulatory registrations for the product and working as part of a cross functional team to ensure that they are adequately addressed.
• Communicates directly with notified bodies, distribution partners, Cook affiliates and other regulatory authorities to ensure product approvals are achieved in a timely manner.
• Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
• Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner.
• Provides support to currently marketed products as necessary including input on change requests, regulatory restrictions, etc.
• Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
• Provides regulatory support to Cook functional units such as the SSC, tenders, customer quality and distribution.
• Performs additional duties as assigned. Can act as a designee for other Regulatory Affairs Specialists if required. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

Qualifications

• Third level Qualification preferably in Science/Engineering; 3-5 years experience in a regulated industry in a similar role desirable
• Knowledge of relevant ISO, EU, FDA medical device standards regulations is required.
• Knowledge of medical device quality standards/practises or similar regulated industry.
• 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 and availability to travel on company business.