Overview
Regulatory Affairs Specialist Medical Devices - 12 month Fixed Term Contract (with potential to go)
Vision RT is a rapidly growing MedTech transforming radiation therapy for cancer patients. We are the inventors and market leaders in Surface Guided Radiation Therapy (SGRT). Our SGRT solutions are used in 24 of the 25 Best Hospitals for Cancer, as tracked by US News & World Report. Vision RT is part of William Demant Invest A/S, offering the security of a large global enterprise with startup agility.
This role sits within the Quality and Regulatory team and is responsible for obtaining and maintaining marketing approvals for Vision RT products globally, implementing the regulatory strategy, and providing regulatory expertise to support business development. The Regulatory Affairs (RA) Specialist reports to the Regulatory Affairs Manager.
Responsibilities
* Lead on Vision RT product submissions to competent authorities in line with the product development roadmap and market expansion strategy, primarily EU and US, with travel as needed.
* 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 implement strategies to meet new requirements to ensure business continuity in target markets.
* Liaise with internal and external stakeholders, providing training and support to ensure regulatory requirements are met.
* Prepare and submit pre- and post-market reports to regulators and local representatives.
* Maintain Technical Documentation to ensure regulatory compliance with applicable standards, regulations and guidance.
* Act as an auditor of internal functions and external suppliers.
* Perform other duties to support the company\'s quality policy and objectives.
* Occasional UK and international travel.
Essential Skills & Experience
* Regulatory Affairs experience in a medical device company.
* ISO 13485 or MDSAP.
* Experience with CE marking (MDR) and/or preparing US 510(k) submissions.
* Competent with 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 with 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 without regard to race, colour, religion, sexual orientation, gender, national origin, disability, or protected veteran status.
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