SENIOR REGULATORY SPECIALIST – MEDICAL DEVICE

CARDIFF/TREDEGAR

PERMANENT FULL TIME

SALARY £40K - £50K PLUS BENEFITS

We are seeking a meticulous Regulatory Specialist to join our Clients’ team. The successful candidate will play a crucial role in ensuring compliance with regulatory requirements within our Clients’ organisation.

This position is a full time (40hours per week) role, fully office based either in Tredegar or Cardiff.

Main purpose of job:

Provide leadership on regulatory affairs, supporting NPD project, maintain compliance of products, support audits, owning risk management file and CER, developing and implementing RA strategy, product surveillance, preparation of tech file, submission of regulatory applications and communications with international regulatory approvals. Be part of the NPD team, reviewing and approving documents, involve in design and stage gate reviews. Surveillance of new standards and ensuring NPD meets recognise consensus standards, etc. Involve in CAPA team to resolve issues.

Qualifications required:

BEng/BSc in Engineering or Science or related field with RA experience in medical device industry. BEng/BSc in mechanical/medical/biomedical/materials engineering is an advantage.

Experience required:

• At least 4 years RA experience in Class 1 medical device as essential (Class 2 will be desired) for major territories FDA, UKCA and MDR is essential. Additional knowledge for Canada, Australia, Japan registration will be desired.
• Design and implement QMS for design control, be part of NPD team and remediation activities to prepare and maintain tech files to ensure continuous compliance. Good knowledge of ISO13485 and ISO14791 and maintenance of RMF.
• Timely preparation of submissions and communication with regulatory organisations such as Q-sub and eSTAR with FDA, etc.
• Develop and implement regulatory strategy for NPD and existing products to maintain compliance.

Essential skills:

• Able to lead RA activities and be the first point of contact for compliance enquiries.
• Good communication skills and can effectively communicate with regulatory, legal, R&D, sustaining engineering, sales and operations.
• Able to work with NPD teams.
• Computer skills
• Able to manage day-to-day activities and tasks, and work independently in RA matters

Key personal attributes:

• “Can do” attitude; A “finisher” and drive to complete projects, with a track record of products from start to launch
• Honesty and integrity
• Dependability and reliability
• Flexibility and willingness to work collaboratively
• Emotional intelligence and creativity
• Committed to professionalism and continuous improvement and personal development
• Must have a positive & optimistic attitude, very responsive and helpful always
• Customer and patient focus – safety and usability
• Team player - working as part of a close-knit team

Other desirable skills / experience:

• Class 2A/B medical device experience
• Good regulatory application knowledge on other territories in addition to FDA/UKCA/MDR
• Clinical knowledge in tissue viability is desirable

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Recruitment Solutions Workforce Limited offers the services of an employment agency for permanent roles and an employment business for temporary roles.