Medical Device Regulatory Professional

Key ResponsibilitiesThis role involves maintaining expertise in global medical device regulations, communicating regulatory requirements, and serving as a liaison between stakeholders. Key areas of focus include:• Understanding and applying ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745, and FDA QSP 21CFR Part 820 standards and...

About the RoleThe Regulatory Scientist 2 plays a pivotal role in ensuring the compliance of Cook Medical's medical devices with global regulations. This position requires an individual with excellent knowledge of post-market surveillance and clinical evaluation requirements.Key ResponsibilitiesMaintain an excellent understanding of global medical device...

Job DescriptionCook Medical is seeking a highly skilled Regulatory Scientist 2 to join our team. The successful candidate will have excellent knowledge of global medical device regulations, including EU MDR 2017/745, ISO13485, MDD 93/42/EEC, and FDA QSP 21CFR Part 820.Key ResponsibilitiesImplement regulatory requirements in accordance with EU MDR 2017/745,...

Job Summary:We are seeking a highly skilled Regulatory Affairs Specialist 2 to join our team at Cook Medical. In this role, you will be responsible for ensuring the company's medical devices comply with relevant regulations and standards.Key Responsibilities:Maintaining up-to-date knowledge of regulatory requirements in accordance with ISO 13485, MDD...

Requirements and Qualifications:To be successful in this role, you should possess:Qualifications:A third-level qualification preferably in Science/Engineering or Law.2-5 years' experience in a regulated industry in a similar role desirable.Knowledge and Skills:Ideal knowledge of European Medical Devices Regulation (EU-MDR), Regulation (EU) 2017/745, and...

Job SummaryThe Regulatory Affairs Specialist 2 works closely with cross-functional teams to develop and implement regulatory strategies. The primary goal is to ensure compliance with applicable regulations and facilitate the commercialization of medical devices in targeted markets. Key responsibilities include:• Maintaining current knowledge of regulatory...

Are you passionate about quality and regulatory affairs? Do you want to gain practical experience in a fast-paced medical device environment?About the Opportunity:We are seeking a talented individual to join our Cooperative Quality Professional program at TN Ireland.In this role, you will work collaboratively with your team to identify improvement projects,...

Job DescriptionCook Medical Incorporated is hiring a Regulatory Affairs Specialist 2 to support the development and implementation of regulatory strategies for medical devices. As a key member of the regulatory team, you will work closely with cross-functional teams to ensure compliance with regulatory requirements and standards.Key responsibilities...

Cook Medical's Regulatory Scientist 2 plays a critical role in ensuring the company's medical devices comply with global regulations. The ideal candidate will have experience in regulated industries and a strong understanding of post-market surveillance and clinical evaluation regulations.Responsibilities:Develop and implement regulatory strategies to ensure...

Clinical and Post Market SurveillanceAt Cook Medical, we are committed to delivering innovative medical devices that improve patient outcomes. As a Regulatory Scientist 2, you will play a critical role in ensuring the safe and effective use of our products. Your responsibilities will include:Maintaining an excellent understanding of global medical device...

Job OverviewThe position of Regulatory Affairs Specialist 2 at Cook Medical Incorporated is responsible for developing regulatory strategies and performing activities associated with obtaining and maintaining regulatory approval to commercialize medical devices in selected target markets.This role serves as a communication liaison between the manufacturer...

About the RoleThis is an exciting opportunity to lead a team of engineers focused on research, development, and implementation of new medical device designs.As a technical leader within the project team, you will be responsible for leading key design decisions, managing device evaluations, and ensuring compliance with Quality, Regulatory, and company...

About the PositionWe are seeking a talented Regulatory Scientist 2 to join our team at Cook Medical. As a key member of our regulatory affairs department, you will play a vital role in ensuring the compliance of our medical devices with global regulations.Key ResponsibilitiesDevelop and implement regulatory strategies for Cook Medical's medical...

About Us:Cook Medical is a leading manufacturer of medical devices, committed to providing high-quality products that meet the needs of healthcare professionals and patients.The Role:This exciting opportunity has arisen for a highly skilled and experienced Quality Assurance professional to join our team in Cook Medical Europe Ltd. As a Quality Assurance...

Career OpportunityCook Medical Incorporated is a leading medical device manufacturer seeking a Regulatory Affairs Specialist 2 to join their team. As a key member of the regulatory team, you will be responsible for developing and implementing regulatory strategies to obtain and maintain approval for medical devices in targeted markets.In this role, you will...

About the RoleWe are seeking an experienced individual to join our production team as a Manufacturing Operator. In this role, you will be responsible for assisting in the manufacture and shipment of medical device products.Key Skills and Qualifications:Experience in a production environment preferred.Previous experience in medical devices advantageous.Good...

OverviewThe Regulatory Affairs Specialist 2 plays a crucial role in developing regulatory strategies to secure approval for medical devices in target markets. This specialist serves as a liaison between the manufacturer and local affiliates, distribution partners, or regulatory authorities. Reporting directly to the Team Lead, Regulatory Affairs or Manager,...

Job Title: Regulatory Affairs Specialist 2Description:The Regulatory Affairs Specialist 2 will play a key role in supporting the development and implementation of regulatory strategies for Cook Medical's medical devices. This includes maintaining a thorough understanding of global medical device regulations and communicating regulatory requirements to...

Job Description:The Regulatory Affairs Specialist 2 at Cook Medical plays a crucial role in developing and implementing regulatory strategies for medical devices. This position requires a deep understanding of global regulations, including ISO 13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745, and FDA QSP 21 CFR Part 820.Responsibilities:Maintain...

OverviewCook Medical is a leading medical device company with a strong presence in Europe. We are seeking an experienced leader to drive innovation and development of our products.This role will lead a team of engineers focused on research, development, and implementation of new medical device designs.