Regulatory Affairs Specialist

OverviewCook Medical is a leading manufacturer of medical devices, and we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will play a crucial role in ensuring that our products meet the highest standards of quality and safety.ResponsibilitiesAssist in the running of Cook...

PSC Biotech Corporation is a leading provider of cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services.We are seeking an experienced Regulatory Affairs Specialist to join our team. The successful candidate will have experience working in a regulated GxP...

CPS, Inc. Job DescriptionJob Title:Regulatory Affairs SpecialistOverviewCPS, Inc. is seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring compliance with global chemical regulations and providing chemical regulatory support to ink development and maintenance teams.Key...

Job OverviewThe Regulatory Scientist 2 plays a vital role in developing regulatory strategies, ensuring compliance with global medical device regulations for specific jurisdictions.Maintains an excellent understanding of regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part...

Overview The Regulatory Affairs Specialist 2 ensures regulatory compliance to the EU MDR at the office of the EU Authorised representative (AR). The EU AR Office is responsible for verifying compliance to the EU MDR on behalf of Cook Medical's non-EU manufacturers. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook...

Job Description:The Senior Regulatory Scientist role is a critical position in the regulatory affairs team, responsible for assisting in the running of regulatory programmes and providing input into regulatory strategies.Key responsibilities include implementing regulatory requirements, maintaining an excellent understanding of global medical device...

OverviewCook Medical is a leading medical device company that develops and manufactures innovative products to improve patient outcomes. We are seeking a highly skilled Regulatory Affairs Expert to join our team.

We're looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver...

OverviewThe Regulatory Scientist 2 will be involved in the development and generation of post market surveillance (PMS) plans and reports for Cook Ireland medical devices. In addition, the Regulatory Affairs Specialist will perform activities associated with PMS, including Post Market Clinical Follow-Up (PMCF), and Clinical Evaluation Plans and Reports...

Overview The primary role of the Senior Regulatory Scientist is to assist in the running of the regulatory affairs by providing input into: regulatory strategies, performing activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets and providing regulatory affairs input for the...

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

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

Job SummaryPale Blue Dot Recruitment is seeking a highly skilled Senior Regulatory Affairs Specialist to join their team. In this role, you will be responsible for developing and implementing regulatory strategies to support the successful registration, approval, and maintenance of company and client products.Main ResponsibilitiesDevelop and implement...

Role Summary:This is an exciting opportunity for a highly skilled and experienced professional to join our regulatory affairs team as a Senior Regulatory Scientist.The successful candidate will be responsible for assisting in the running of regulatory programmes, providing input into regulatory strategies, and ensuring compliance with relevant ISO, EU, and...

Job DescriptionMaintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned.Develop global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personnel.Communicate country/region specific regulatory requirements to the regulatory...

Care Services Team OverviewWe are seeking a Quality & Compliance Coordinator to join our dynamic Care Services Team at Mowlam Healthcare Group. The successful candidate will be responsible for supporting the Healthcare Manager in managing regulatory challenges and ensuring delivery of key quality and compliance performance measures.Key ResponsibilitiesFoster...

We're recruiting for a Regulatory Compliance Specialist to join our Medical Device organization based in Limerick. This is an excellent opportunity for anyone who is passionate about regulatory compliance.About the RoleAs a Regulatory Compliance Specialist, you will be responsible for ensuring that our products meet the highest standards of quality and...

Work Flexibility: Onsite This position provides experience of working in a regulated medical device company. You will have the opportunity to develop and apply basic knowledge and understanding of the quality, regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.  Additionally, this opportunity provides good...

About the Role:We are looking for a highly motivated and experienced Regulatory Compliance Specialist to join our team at Regeneron Ireland DAC. As a QA Specialist, you will be responsible for ensuring the quality and compliance of our biologics manufacturing operations.Key Responsibilities:Preparation and review of batch disposition documentation to support...

Role OverviewThis role involves providing support and information to individual groups and supervisors with document initiation, review, submission, and follow-up. As a Supply Chain Governance Expert, you will work closely with cross-functional teams to ensure regulatory compliance and drive business growth.ResponsibilitiesFacilitate reviews and revisions of...