Urgent Search Senior Regulatory Scientist

3 days ago

Limerick, Ireland Cook Medical Incorporated Full time

Overview

Device Compliance/NPI:

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.

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.
- 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.

Qualifications

- Third level Qualification preferably in Science/Quality Engineering or Clinical (such as Pharmacy or Nursing)
- 5 years’ experience in a regulated industry in a similar role is desirable.
- 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 21CFR Part 820 as required.
- Knowledge of requirements in other jurisdictions where required.
- 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
- Proven organisational skills.
- High self-motivation.
- Willingness and availability to travel on company business.

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