Senior Regulatory Affairs Specialist – Medical Devices

at  Vision RT Ltd

Vision RT is a rapidly expanding MedTech company at the forefront of transforming radiation therapy. We are the inventors of Surface Guided Radiation Therapy (SGRT), which harnesses advanced 3D camera systems and sophisticated AI, Computer Vision, and Machine Learning software. Our mission is to enhance the safety, precision, and comfort of radiation therapy for patients. Notably, our innovative solutions are deployed across all 15 of the prestigious “Best Hospitals for Cancer,” as recognized by US News & World Report
Company video: https://youtu.be/ci5BrRrp4h0
With around 300 employees globally, and offices in the UK, Poland & US, we operate autonomously as part of the Danish company Demant A/S, one of the largest healthcare companies in the world.

ESSENTIAL SKILLS & EXPERIENCE

• At least 5 years’ experience in a medical device company in a Regulatory Affairs role.
• Experience of CE marking (MDR) medical devices and/or preparing US 510(k) (FDA) submissions.
• Competent in Microsoft Word, Excel, PowerPoint, Outlook and general computer usage.
• Fluent in written and spoken English.

DESIRABLE SKILLS & EXPERIENCE

• A degree/qualification in health sciences, medical engineering, law or similar field.
• Experience of internal and/or supplier audits to ISO 13485, MDSAP and/or ISO 9001.
  Vision RT is an Equal Opportunity / Affirmative Action employer, all qualified applicants will receive consideration for employment and development without regard to race, colour, religion, sexual orientation, gender, national origin, disability, or protected veteran status

ABOUT THE ROLE

The position sits within the Quality and Regulatory team. You will play a pivotal role in obtaining, and maintaining marketing approvals for Vision RT products globally, implementing the firms regulatory strategy and provide regulatory expertise to support business development. The Senior RA Specialist will report into the Regulatory Affairs Manager.

KEY RESPONSIBILITIES WILL INCLUDE:

• Lead on Vision RT’s product submissions to competent authorities in line with the company’s product development roadmap and market expansion strategy, with a general focus on EU and US but also including RoW.
• Act as an extended member of the R&D team to develop and implement regulatory plans for new and changed products.
• Monitor and analyse changes in the regulatory environment and implementing strategies for meeting new and changed requirements to ensure business continuity in target markets.
• Liaise with internal and external stakeholders, providing training and support to ensure that regulatory requirements are met.
• Prepare and submit pre- and post-market reports to regulators and local representatives.
• Plan and perform clinical evaluations of the company’s medical devices.
• Maintain Technical Documentation to ensure that the company’s compliance with applicable standards, regulations and guidance is documented.
• Act as a senior member of the Quality & Regulatory Compliance team, mentoring and supporting peers and junior colleagues.
• Act as an auditor of internal functions and external suppliers.
• Act as a Subject Matter Expert for internal and external audits.
• Other duties in support of the company’s quality policy and objectives.
• Occasional UK and international travel.