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medical device reprocessor
Title posted on indeed.com - MDR Medical Device Regulation
Posted on September 24, 2024 by Employer details Patodia Eye Institute
Job details
*Job Summary* We are seeking a knowledgeable and detail-oriented MDR Medical Device Regulation professional to join our team. The ideal candidate will be responsible for ensuring compliance with medical device regulations and standards, particularly in relation to the European Union's Medical Device Regulation (MDR). This role is crucial in maintaining the quality and safety of our medical devices while navigating the complex regulatory landscape. *Duties* - Review and interpret relevant medical device regulations, including the EU MDR, to ensure compliance throughout the product lifecycle. - Prepare and maintain technical documentation required for regulatory submissions, including Clinical Evaluation Reports (CERs) and Technical Files. - Collaborate with cross-functional teams, including R&D, Quality Assurance, and Marketing, to ensure regulatory requirements are integrated into product development processes. - Liaise with regulatory authorities and notified bodies during audits and inspections. - Stay updated on changes in regulations and industry standards that may impact the organization?s products. - Provide training and guidance to internal teams on regulatory requirements and best practices. *Experience* - Proven experience in medical device regulation, particularly with EU MDR compliance. - Strong analytical skills with attention to detail. - Excellent communication skills, both written and verbal, with the ability to convey complex regulatory information clearly. - Ability to work independently as well as collaboratively within a team environment. This role is essential for ensuring that our medical devices meet all necessary regulatory requirements while maintaining high standards of safety and efficacy. If you are passionate about medical device regulation and want to make a meaningful impact in the healthcare industry, we encourage you to apply. Job Type: Part-time Work Location: In person- LocationSarnia, ON
- Workplace information On site
- SalaryNot available
- Terms of employment Part time
- Starts as soon as possible
- vacancies 1 vacancy
- Source indeed.com #9458306640
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