Only 24h Left: Regulatory Scientist 2

4 days ago

Limerick, Limerick, Ireland Cook Medical Full time

Overview The primary role of the Senior Regulatory Scientist is to assist in the running of the regulatory affairs by providing input into: regulatory strategies, performing activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets and providing regulatory affairs input for the functional areas. Reporting to: Principal Regulatory Scientist Responsibilities Assists in the running of the Cook Ireland regulatory affairs programmes in accordance with internal procedures and regulatory requirements. Responsibility for assisting in implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA 21CFR Part 820 as required and other jurisdictions as required. Knowledge of relevant ISO, EU, FDA medical device standards regulations is required. Maintains an excellent understanding of the global medical device regulations. Maintains a thorough understanding of the products assigned to the team. Works to improve the function of the Regulatory Affairs Department. Understands the progress of the RA team on assigned tasks and removes roadblocks. Provides support to the RA team members to complete assigned tasks. Mentors and trains new RA team members. Highlights any updates to regulatory requirements to regulatory management. Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed or collaborates with their assigned regulatory specialists on same. Reviews submissions generated for their assigned regulatory area to ensure compliance to the regulations in that particular jurisdiction. Develops 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 etc) of the requirements in each target market and updates same on approval status in target markets. Ensures the clinical requirements of the product are adequately addressed. Ensure the outputs from the individual functional units (engineering, marketing etc.) meet the applicable regulatory requirements. Communicates status of projects / submissions directly to RA Management and other stakeholders as required. Communicates directly with regional regulatory agencies / notified bodies to ensure product clearances are achieved in a timely manner. Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner. Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required. Maintains a system for registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability. Provides support to currently marketed products as necessary including input on change requests, 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. Is a delegate for the Senior Manager Post Market Surveillance, Regulatory Affairs / Manager, Regulatory Affairs, Principal Regulatory Scientist. Is a delegate for the Regulatory Affairs Specialist. Is a delegate for the Team Lead, Regulatory Affairs. Other General Responsibilities Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf. Perform additional duties as assigned. Qualifications Third level Qualification in any of the following areas: Science, Engineering, or Clinical. 2 years' experience in a regulated industry in a similar role would be advantageous. Knowledge of regulations pertaining to Post-market Surveillance and Clinical Evaluation would be advantageous. Particularly in relation to the EU (MDD 93/42/EEC, EU MDR 2017/745). (Clinical & Post Market Surveillance Role) Ideally have knowledge of requirements in MDSAP countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required. Good communication and inter-personal skills with ability to communicate clearly and concisely in both spoken and written form. Participate in a team-based environment. Proven problem-solving skills. Good technical writing skills; advantageous to have medical writing experience. Knowledge / use of search databases for published literature (Embase, PubMed etc.) Good computer skills including knowledge of Microsoft Office. Proven organisational skills. High level of self-motivation. Willingness and availability to travel on company business as required. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.

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    4 days ago

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