2 weeks ago Be among the first 25 applicants
EVAT Master, founded in 2019 and headquartered in Shenzhen, is China’s leading SaaS platform specializing in automated VAT & EPR compliance services across Europe and beyond.
We collaborate with a highly experienced team of international accountants, tax consultants, and IT professionals to drive the industry towards intelligence, professionalism, and regulatory compliance.
We serve a vast customer base, including Chinese cross-border e-commerce merchants selling on Amazon, eBay, and AliExpress. Our technology is integrated with official tax compliance systems across multiple countries, including Germany, the UK, France, Italy, Spain, Poland, Austria, and the Middle East.
* About the Role:
We are currently seeking a qualified Person Responsible for Regulatory Compliance (PRRC) to support our regulatory activities for medical devices in the EU, UK, and Turkey. This is a remote, part-time freelance position ideal for candidates located in Northern Ireland with a valid EU work visa and the appropriate regulatory expertise.
* Key Responsibilities:
* Act as our PRRC under EU MDR/IVDR for medical device regulatory compliance.
* Complete and support EUDAMED registration using your personal identification and professional credentials.
* Be available (estimated ~80 hours/year) to assist with communications to government authorities and notified bodies when needed.
* Ensure compliance with applicable EU regulations, particularly MDR (EU 2017/745) and/or IVDR (EU 2017/746).
* Provide support in regulatory document review and updates, as required.
* Required Qualifications
* Nationality: Residents of Northern Ireland or those with a work visa for Northern Ireland
* Work Authorization: Hold a valid EU work visa (essential for EUDAMED PRRC eligibility).
* Education & Experience:
* A university degree (or equivalent qualification) in law, medicine, pharmacy, engineering, or other relevant science disciplines AND at least 1 year of professional experience in regulatory affairs or quality management systems related to medical devices.
* Alternatively, at least 4 years of professional experience in regulatory affairs or quality management systems in the medical device sector.
Professional Knowledge:
* Strong understanding of EU MDR/IVDR requirements.
* Preferred: Experience with ISO 13485 or other international regulatory frameworks.
* Experience with EUDAMED registration is a plus.
Seniority level
* Seniority level
Entry level
Employment type
* Employment type
Part-time
* Industries
Information Services
Referrals increase your chances of interviewing at Shenzhen EVAT MASTER Technology Co., Ltd by 2x
Get notified about new PRRC + Northern Ireland jobs in Northern Ireland, United Kingdom.
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr