Regulatory Affairs Associate

2 weeks ago

Renfrew, United Kingdom Terumo Aortic Full time

_**Terumo Aortic are looking for a Senior Regulatory Affairs Associate 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:

- **_
- Assist in the production and review of design dossiers technical files, and Product Approval Certificates.
- Preparation of regulatory submission for product approvals.
- Preparation of Custom Made device, Special Products paperwork and change assessments.
- Participate in Design Control, Risk Management, Post Market Surveillance and document changes.
- Facilitate compliance with Vigilance System.
- Update and review all IFU, Packaging and Labelling
- Other duties as required by Regulatory Affairs department
- **Qualifications & Experience:

- **_
- BSc Hons Degree or equivalent.
- Regulatory experience within a medical device or pharmaceutical environment is desirable.

**Job Types**: Full-time, Permanent

**Benefits**:

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

Schedule:

- Monday to Friday

Supplemental pay types:

- Bonus scheme

Work Location: Hybrid remote in RENFREW

  • Regulatory Affairs Team Leader

    2 weeks ago

    Renfrew, United Kingdom Terumo Aortic Full time

    _**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: - **_ -...

  • Medical & Scientific Writer

    7 days ago

    Renfrew, United Kingdom Terumo Aortic Full time

    Terumo Aortic is a leading global medical device company dedicated to advancing medical technology and ensuring regulatory compliance. We are experiencing a time of unprecedented growth and investment, and we invite you to join our dynamic team. We are currently looking for a Medical and Scientific Writer (I) in our Clinical Affairs department, you will play...

  • Clinical Research Assistant

    2 weeks ago

    Renfrew, United Kingdom Terumo Aortic Full time

    Terumo Aortic are currently looking to recruit a Clinical Research Assistant on a FTC for 12months. This is an excellent opportunity to develop your career whilst making a real difference. The main responsibilities of the role are; - Assist the Clinical Affairs Department with Clinical Investigation/study and Post Market Clinical Follow Up (PMCF) activities...

  • Senior Quality Engineer

    7 days ago

    Renfrew, United Kingdom Terumo Aortic Full time

    Senior Quality Engineer - Risk Management Join to apply for the Senior Quality Engineer - Risk Management role at Terumo Aortic Are you an experienced quality professional with a passion for risk management and regulatory compliance in the medical device industry? Terumo Aortic is seeking a Senior Quality Engineer – Risk Management to join our Quality...

  • Principal Ra

    2 weeks ago

    Renfrew, United Kingdom Terumo Aortic Full time

    Terumo Aortic are looking for a Principal RA 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. The main responsibilities of the role are; -...

  • HSE Advisor

    3 weeks ago

    Renfrew, United Kingdom Brightwork Full time

    Our client is currently recruiting a HSE Advisor to support the EH&S Manager and wider EH&S department in communicating and driving a culture of continuous improvement throughout the company.Responsibilities Liaise with a range of business functions and departments as necessary to ensure that Company activities are undertaken in accordance with the EH&S...

  • Engineering Lead

    2 weeks ago

    Renfrew, United Kingdom Terumo Aortic Full time

    Terumo Aortic is seeking an experienced Engineering Lead – Commercial to lead the team responsible for research and development work associated with the day‑to‑day development of existing commercially available surgical and hybrid products. Lead the team in maintenance, NCRs, CAPAs, complaints, and design changes associated with the existing commercial...