Regulatory Affairs Specialist

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,...

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,...

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...

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.

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...

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...

Social network you want to login/join with:Regulatory Affairs Specialist 2 (Hybrid), LimerickClient:Cook MedicalLocation:Limerick, IrelandJob Category:OtherEU work permit required:YesJob Reference:5c63328c9fe6Job Views:65Posted:22.01.2025Job Description:OverviewThe Regulatory Affairs Specialist 2 ensures regulatory compliance to the EU MDR at the office of...

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...

Job DescriptionThe Regulatory Affairs Specialist ensures regulatory compliance to the EU MDR at the office of the EU Authorised representative (AR). The AR Office is responsible for verifying compliance to the EU MDR on behalf of Cook Medical's non-EU manufacturers.Main Responsibilities:Maintain a thorough understanding of the medical device regulations of...

About the RoleThis exciting opportunity has arisen for 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 serve as a...

What We're Looking ForWe are seeking a highly motivated and experienced Regulatory Affairs Specialist 2 to join our team at Cook Medical. In this role, you will be responsible for ensuring regulatory compliance to the EU MDR at the office of the EU Authorized Representative (AR).

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...

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...

QCS Staffing is excited to announce a 12-month contract opportunity for a Regulatory Affairs Writer in Limerick. If you have a passion for creating compelling content and staying up-to-date with the latest regulatory requirements, this could be the perfect fit for you.The Life Sciences sector in Ireland is booming, with companies investing heavily in...

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,...

OverviewThe Senior Regulatory Scientist plays a pivotal role in the regulatory affairs department, providing strategic input and expertise to ensure compliance with global medical device regulations.

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...

About the RoleThe Regulatory Affairs Specialist 2 ensures regulatory compliance to the EU MDR at the office of the EU Authorised representative (AR).Key Responsibilities:Maintain an excellent understanding of medical device regulations, including EU MDR, EMEA, and EN ISO 13485.Work with the global project manager EU MDR and other team members to implement EU...