Regulatory Affairs Associate
7 days ago
_**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
7 days 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 months ago
Renfrew, United Kingdom Terumo Aortic Full timeTerumo 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
7 days ago
Renfrew, United Kingdom Terumo Aortic Full timeTerumo 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...
-
Biostatistician
1 week ago
Renfrew, United Kingdom Terumo Aortic Full timeTerumo Aortic have an exciting opportunity for an experienced Biostatistician to join our Clinical Affairs department. The successful individual will be responsible for providing statistical and data management support to clinical study teams based in both Glasgow and Florida. Key Duties - Collaborates in the design, analysis, and reporting of clinical...
-
Principal Ra
7 days ago
Renfrew, United Kingdom Terumo Aortic Full timeTerumo 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; -...
-
Environmental Health
7 months ago
Renfrew, United Kingdom Terumo Aortic Full timeTerumo Aortic are currently recruiting for an Environmental Health & Safety Coordinator to join our team during an exciting time of growth and investment on site. This is an excellent role working alongside our experienced team and offering fantastic career opportunities. The main responsibilities of the role are; - Ensure Environmental Health and Safety...
-
Events Planner
2 days ago
Renfrew, United Kingdom Terumo Aortic Full timeKey Duties; - Organise virtual and in-person internal and external events from concept to execution including all logistics - Develop a digital planning strategy for EMEA congresses - Manage Associate attendance at EMEA congresses - Work with product marketing, medical affairs on programme of activities at congresses - Work with internal design team on...
-
Medical Writer
1 week ago
Renfrew, United Kingdom Terumo Aortic Full time**_Terumo Aortic have an exciting new role for a Medical Writer to join our talented and experienced team. This is a fantastic opportunity for someone to join the team and be able to add real value whilst continue to grow their career. _** **_The main objectives of the role are; _** - Write, contribute to and manage the review/approval of the following...
-
Complaints Investigator
4 days ago
Renfrew, United Kingdom Terumo Full timeTerumo Aortic are currently looking to recruit a Complaint Investigator to join our busy and expanding quality team. This is an exciting role that offers individuals the chance of career progression and to add to real value to the business. The main responsibilities of the role are; - As part of a dedicated Complaints function, develop and maintain all...
-
Manufacturing Technical Author
8 months ago
Renfrew, United Kingdom Terumo Aortic Full timeKey duties: - Provide documentation in form of work instructions, procedures and records to support the transfer of products and processes into TA Glasgow and from TA Glasgow to external critical suppliers - Work with Manufacturing Engineers and Quality Engineers across various sites in order to ensure timely duplication of procedures and work instructions...
-
Manufacturing Technical Author
8 months ago
Renfrew, United Kingdom Terumo Aortic Full timeKey Duties; - Provide documentation in form of work instructions, procedures and records to support the transfer of products and processes into TA Glasgow and from TA Glasgow to external critical suppliers - Work with Manufacturing Engineers and Quality Engineers across various sites in order to ensure timely duplication of procedures and work instructions...
-
Manufacturing Technical Author
1 week ago
Renfrew, United Kingdom Terumo Aortic Full timeKey duties: - Provide documentation in form of work instructions, procedures and records to support the transfer of products and processes into TA Glasgow and from TA Glasgow to external critical suppliers - Work with Manufacturing Engineers and Quality Engineers across various sites in order to ensure timely duplication of procedures and work instructions...