Team Leader - Regulatory Affairs

TN United Kingdom; Inchinnan; On-site; GBP 45,000 - 75,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Team Leader to drive compliance and innovation during a period of exciting growth. This role offers a unique opportunity to lead regulatory documentation preparation, develop strategies for product approval, and mentor a dedicated team. Join a forward-thinking company that values career development and provides a supportive environment for professional growth. If you are passionate about regulatory affairs and want to make an impact in a dynamic setting, this position is perfect for you.

Qualifications

• Experience in preparing regulatory submissions and documentation.
• Strong knowledge of international regulatory standards.

Responsibilities

• Lead the preparation and review of regulatory documents for product approval.
• Mentor team members and provide regulatory input to various groups.

Skills

Regulatory Documentation

Risk Management

Design Control

Product Approval

Mentoring

Education

Bachelor's Degree in Life Sciences

Relevant Regulatory Affairs Certification

Job description

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Team Leader - Regulatory Affairs, Inchinnan

Client:

Location: Inchinnan, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: a8ac8a04c73e

Job Views: 7

Posted: 26.04.2025

Expiry Date: 10.06.2025

Job Description:

Terumo Aortic is seeking a Regulatory Affairs Team Leader to join during an exciting period of growth and expansion. This role offers an excellent opportunity for career development within a company that provides many benefits.

Key Duties:

1. Preparation and review of regulatory documentation and submissions for product approval.
2. Development of regulatory plans and strategies for new and existing products.
3. Participation in Design Control, Risk Management, and Post Market Surveillance activities.
4. Production and review of design dossiers, technical files, and change assessments.
5. Review and preparation of regulatory paperwork in line with international standards and new regulations.
6. Review of product packaging, labelling, Instructions for Use (IFUs), and marketing literature for compliance with country-specific regulations.
7. Facilitate compliance with Vigilance System.
8. Provide regulatory input to various functional groups.
9. Participate in reviewing RA procedures.
10. Review and approve validation protocols and reports.
11. Mentor RA Associates.
12. Perform other duties as required by the Regulatory Affairs department.