Medical Device Regulatory Affairs Specialist

Overview The Regulatory Affairs Specialist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates,...

Overview The Regulatory Affairs Specialist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets.The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates,...

Overview The Regulatory Affairs Specialist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets.The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates,...

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 seeking a highly skilled Regulatory Affairs Specialist 2 to join our team. This role will play a crucial part in developing regulatory strategies and ensuring compliance with global medical device regulations.The ideal candidate will have excellent communication skills, both written and verbal, and be able to work effectively in a...

OverviewThe Regulatory Affairs Specialist 2 helps develop regulatory strategies and performs activities associated with obtaining and maintaining regulatory approval to commercialize medical devices in selected target markets. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates,...

OverviewCook Medical seeks a highly skilled Regulatory Affairs Specialist 2 to develop and implement regulatory strategies for commercializing medical devices in target markets.This role serves as a liaison between the manufacturer and local affiliates, distribution partners, or regulatory authorities, ensuring effective communication and collaboration.

OverviewCook Medical Incorporated seeks a highly skilled Regulatory Affairs Specialist 2 to join their team. This role involves developing regulatory strategies and performing activities associated with obtaining and maintaining regulatory approval to commercialize medical devices in selected target markets.The successful candidate will serve as a...

Job Summary:We are seeking a seasoned Medical Device Compliance Specialist to join our regulatory affairs team. As a key contributor, you will be responsible for ensuring compliance with regulatory requirements for our medical devices in targeted markets.You will work closely with cross-functional teams to develop and implement regulatory strategies,...

Cook Medical is seeking a highly skilled Regulatory Affairs Specialist to join our team.The successful candidate will be responsible for developing and implementing regulatory strategies for Cook medical devices, ensuring compliance with global regulations such as the EU Medical Device Regulation (2017/745) and FDA QSP 21CFR Part 820.The ideal candidate will...

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...

Key ResponsibilitiesThe Regulatory Affairs Specialist 2 plays a critical role in ensuring the company's medical devices meet regulatory requirements.This includes:Maintaining a deep understanding of global medical device regulations.Developing and implementing regulatory strategies.Communicating regulatory requirements to internal stakeholders.Ensuring...

EU MDR Compliance SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist 2 to join our team in Limerick, Ireland. As a key member of the Regulatory Affairs team, you will be responsible for ensuring regulatory compliance with the EU MDR at the office of the EU Authorised Representative.The successful candidate will have a strong...

Job Description:The Regulatory Scientist 2 plays a crucial role in developing regulatory strategies for medical devices, ensuring compliance with global regulations. This involves performing activities associated with obtaining and maintaining regulatory approval in selected target markets.Main Responsibilities:Maintain an excellent understanding of global...

Role OverviewThe Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the EU regulatory authorities.Main Tasks:Maintain up-to-date understanding of medical device regulations, including EU MDR, EMEA, and EN ISO 13485.Work closely with global project manager EU MDR and other team members to implement EU MDR...

Cook Medical's Regulatory Affairs department is seeking a talented Medical Device Regulatory Expert to support the development and implementation of regulatory strategies for our medical devices.The successful candidate will have a deep understanding of medical device regulations, including ISO 13485, MDD 93/42/EEC, and FDA QSP 21CFR Part 820.This role...

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,...

About the RoleWe are looking for a highly motivated and experienced Regulatory Affairs Specialist 2 to join our team. As a key member of our regulatory affairs team, you will play a critical role in ensuring the commercialization of our medical devices in target markets.In this role, you will:Develop and implement regulatory strategies that meet the...

OverviewCook Medical is seeking a highly skilled Regulatory Scientist 2 to join our team. In this role, you will be responsible for the development and generation of post market surveillance (PMS) plans and reports for Cook Ireland medical devices.In addition, you will perform activities associated with PMS, including Post Market Clinical Follow-Up (PMCF),...

Job Summary:We are seeking an experienced Medical Device Compliance Manager to join our regulatory team. In this role, you will be responsible for ensuring the compliance of our medical devices with global regulations.About the Role:You will develop regulatory strategies for our medical devices, ensuring compliance with global regulations.You will perform...