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.
UK Benefits Package You will become eligible to participate in the company bonus scheme upon successful completion of your probation period. Your bonus will be calculated on a pro‑rata basis from your start date and is aligned with the annual cycle running from January to December. Payments are typically made in February, subject to you being actively employed at the time of payment. This is a discretionary scheme, based on both individual performance and overall company performance. While bonuses are not guaranteed, they have been paid every year for the past decade, with the exception of one year during the COVID‑19 pandemic. Historically, most employees receive between 5% -15%, Pension – We contribute 5% if you contribute 4%. Life Insurance – Coverage is 3x your annual salary. Critical Illness Cover – Provided as part of your benefits package. Gym Contribution – £25 per month towards gym membership and gym next to office Private Health Insurance – Provided via Bupa with no excess; only tax is payable. Healthcare Cash Plan – Covers expenses such as opticians, dental care, physiotherapy, etc. Annual Leave – 25 days of paid holiday per year. Sick Pay – Up to 10 working days of paid sick leave; thereafter, Statutory Sick Pay (SSP) applies. Employee Assistance Programme (EAP)
Associate Complaints Officer in Basingstoke employer: Vision RT
Vision RT is an exceptional employer, offering a dynamic work environment where innovation meets purpose in the MedTech industry. With a strong commitment to employee growth and development, staff enjoy the benefits of being part of a rapidly expanding company that values collaboration and creativity, all while contributing to life-changing advancements in cancer treatment. Located in Basingstoke, employees benefit from a supportive culture that encourages work-life balance and community engagement through initiatives like the Social Committee.
