Post-Market Surveillance (Complaints) Specialist

Vision RT Ltd. • Nashua, NH

5d

About The Position

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.

Requirements

• 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

Nice To Haves

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed