Terumo Aortic are looking for a Regulatory Affairs Team Leader to join our team during an exciting time of growth and expansion for the business. This is a fantastic opportunity for someone to join our Regulatory Affairs team in a rewarding role with a company that offers career development amongst a host of excellent benefits.

Key Duties:-

• Preparation and review of regulatory documentation and submissions for product approval.
• Development of regulatory plans/strategies for new products and changes to existing products.
• Participation in Design Control, Risk Management and Post Market Surveillance activities.
• Production and review of design dossiers, technical files and change assessments.
• Review and preparation of regulatory paperwork in accordance with International standards and new regulations.
• Review of product packaging, labelling, IFUs and marketing literature for compliance with specific country regulations.
• Facilitate compliance with Vigilance System.
• Provide regulatory input to functional groups as required.
• Participate in review of RA procedures.
• Review and approval of validation, protocols and reports.
• Mentorship of RA Associates.
• Other duties as required by Regulatory Affairs department.

Qualifications & Experience:-

• BSc Hons Degree or equivalent.
• 3-5 years regulatory experience within a medical device environment is essential.

Job Types: Full-time, Permanent

Additional pay:

• Bonus scheme

Benefits:

• Additional leave
• Casual dress
• Company pension
• Cycle to work scheme
• Discounted or free food
• Life insurance
• On-site parking
• Sick pay
• Work from home

Schedule:

• Monday to Friday

Ability to commute/relocate:

• RENFREW: reliably commute or plan to relocate before starting work (preferred)

Work Location: Hybrid remote in RENFRE

• Preparation and review of regulatory documentation and submissions for product approval.
• Development of regulatory plans/strategies for new products and changes to existing products.
• Participation in Design Control, Risk Management and Post Market Surveillance activities.
• Production and review of design dossiers, technical files and change assessments.
• Review and preparation of regulatory paperwork in accordance with International standards and new regulations.
• Review of product packaging, labelling, IFUs and marketing literature for compliance with specific country regulations.
• Facilitate compliance with Vigilance System.
• Provide regulatory input to functional groups as required.
• Participate in review of RA procedures.
• Review and approval of validation, protocols and reports.
• Mentorship of RA Associates.
• Other duties as required by Regulatory Affairs department