职位描述
About the role
The Post-Market Surveillance (Complaints) team is backfilling a position after a successful career development. The primary role of the successful applicant will be investigating support tickets, with root-cause analysis as the goal, and regulatory report writing as the end result. It suits someone with a history of investigation, an enquiring mind, and a desire to expand their knowledge within the non-clinical side of Surface Guided Radiation Therapy.
Key Responsibilities
- Assist in the review and classification of complaints against applicable regulations and company procedures to determine reportability.
- Under supervision, work with internal and external stakeholders to investigate complaints, determine the root cause and close or escalate for further action as appropriate.
- Liaise with the Product Risk Management Team and other internal teams to complete initial risk assessments.
- Assist in supporting internal and external audits by Vision RT’s notified body and other third parties.
- Work collaboratively with other teams within the Quality & Regulatory Compliance department and other areas, particularly Production, R&D and Service.
- Once trained, act as an internal auditor to ISO 13485, MDSAP and the EU MDR.
- Other duties as may be reasonably required.
- This role requires occasional UK and international travel.
Essential Skills & Experience
- Strong administration skills and attention to detail.
- Analytical and problem-solving skills.
- Ability to work independently and collaboratively, and ability to prioritise and plan tasks.
- Competent in Microsoft Office products.
- Fluent in written and spoken English
Desirable Skills & Experience
- Advanced MS Excel skills (e.g. VLOOKUP, Pivot Table analysis).
- Demonstrates understanding of navigating medical device regulations and regulatory guidance for regulatory submissions in MDSAP markets and/or the EU.
- Qualified internal auditor with experience of performing internal and/or supplier audits to ISO 13485, MDSAP requirements, the EU MDR and/or ISO 9001.
- 2 years’ experience with Trend Analysis.
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如何申请
关于 Vision RT Ltd.
Vision RT Ltd.
North London or Basingstoke
常见问题
Where is the Post-Market Surveillance (Complaints) Specialist position at Vision RT Ltd. located?
The Post-Market Surveillance (Complaints) Specialist role at Vision RT Ltd. is based in North London or Basingstoke.
What type of employment is the Post-Market Surveillance (Complaints) Specialist role at Vision RT Ltd.?
This Post-Market Surveillance (Complaints) Specialist position is offered as Permanent, Full-time.
What skills are needed for the Post-Market Surveillance (Complaints) Specialist role at Vision RT Ltd.?
Key skills and focus areas for this role include Quality Systems & Complaints.
How do I apply for the Post-Market Surveillance (Complaints) Specialist position at Vision RT Ltd.?
You can apply for the Post-Market Surveillance (Complaints) Specialist role at Vision RT Ltd. directly from this page. Create a professional, ATS-ready resume with Clever CV to strengthen your application before you apply.