Regulatory Affairs Team Leader - Renfrew, United Kingdom - Terumo Aortic
Description
_
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.
- **_
- BSc Hons Degree or equivalent.
- 35 years regulatory experience within a medical device environment is essential.
Job Types:
Full-time, Permanent
Benefits:
- Additional leave
- Casual dress
- Company pension
- Cycle to work scheme
- Discounted or free food
- Life insurance
- Onsite parking
- Sick pay
- Work from home
Schedule:
- Monday to Friday
Supplemental pay types:
- Bonus scheme
Ability to commute/relocate:
- RENFREW: reliably commute or plan to relocate before starting work (preferred)
Work Location:
Hybrid remote in RENFREW
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