
Regulatory Compliance Expert
2 weeks ago
- Define and Execute Regulatory Strategy: Develop regulatory strategies for products, ensuring compliance with US and EU regulations.
- Lead Regulatory Filings: Oversee the preparation and submission of regulatory documents, including 510(k), CE mark submissions, product registrations, and interactions with regulatory agencies.
- Build and Maintain Relationships: Establish and maintain strong relationships with regulatory bodies to ensure successful product approvals.
- Monitor Regulatory Changes: Stay up-to-date with changing regulatory requirements and adapt company strategy accordingly.
- Collaborate with Quality Assurance: Work with Quality Assurance on post-market surveillance and vigilance activities in Europe and the US.
- Review and Approve Materials: Ensure that advertising and promotional materials comply with regulatory requirements.
- Provide Strategic Guidance: Offer regulatory expertise to the leadership team, informing strategic decisions.
- Manage Resources: Lead and develop resources within the regulatory function.
The ideal candidate will have a degree in Engineering, Science, or a health-related discipline, with significant experience in the medical device industry. They should possess proven leadership skills, excellent organisational abilities, and strong communication and interpersonal skills.
-
Regulatory Compliance Expert
7 days ago
Galway, Galway, Ireland beBeeRegulatoryAffairs Full time €66,000 - €97,000Job OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to support our Structural Heart business by developing innovative strategies for regulatory approval and providing strategic leadership to influence the global regulatory environment.Key ResponsibilitiesDirects or performs coordination and preparation of document packages for...
-
Strategic Regulatory Compliance Expert
7 days ago
Galway, Galway, Ireland beBeeRegulatory Full time €93,440 - €107,460Job Title: Regulatory Affairs SpecialistJob SummaryWe are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for coordinating and preparing document packages for regulatory submissions, working with engineers and technical experts to develop robust regulatory strategies, and...
-
Strategic Regulatory Compliance Professional
1 week ago
Galway, Galway, Ireland beBeeCompliance Full time €80,000 - €112,000Regulatory Affairs Specialist Role OverviewBoston Scientific is seeking an experienced Regulatory Affairs Specialist to join our team. This individual will play a crucial role in ensuring compliance with regulatory requirements and facilitating the development of medical devices.Key Responsibilities:Provide regulatory support for product development,...
-
Senior Regulatory Compliance Manager
1 week ago
Galway, Galway, Ireland beBeeRegulatory Full time €60,000 - €80,000Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for managing all regulatory activities, including product certification and compliance, as well as supporting the ongoing maintenance, audit and continuous improvement of specific elements of our Quality Management...
-
Senior Regulatory Compliance Specialist
1 week ago
Galway, Galway, Ireland beBeeRegulatory Full time €40,000 - €80,000Regulatory Affairs SpecialistWe are seeking a detail-oriented and organized Regulatory Affairs Specialist to join our team. As a key member of our regulatory department, you will be responsible for ensuring compliance with government regulations and maintaining accurate records.Key Responsibilities:Monitor and maintain the company's drug or medical device...
-
Regulatory Affairs Compliance Specialist
7 days ago
Galway, Galway, Ireland beBeeRegulatoryAffairs Full time €90,000 - €120,000Our company is seeking a highly skilled Regulatory Affairs Specialist to ensure compliance with global regulatory requirements for medical devices.We require the successful candidate to develop and maintain positive relationships with device reviewers through oral and written communications, assist with policy implementation, provide Regulatory Affairs...
-
Strategic Regulatory Compliance Manager
1 week ago
Galway, Galway, Ireland beBeeRegulatory Full time €95,000 - €118,000Senior Regulatory Affairs SpecialistAs a Senior Regulatory Affairs Specialist, you will play a key role in developing and implementing regulatory strategies to ensure compliance with global medical device regulations. Your primary focus will be on obtaining and maintaining regulatory approval for commercialization of medical devices in selected target...
-
Chief Regulatory Compliance Officer
2 weeks ago
Galway, Galway, Ireland beBeeRegulatoryAffairs Full time €120,000 - €150,000Director of Regulatory Affairs Job DescriptionThe successful candidate will define and lead the company's global regulatory strategy, ensuring successful approvals and market access as the business scales rapidly.Develop and drive global regulatory strategies to support product development, commercialization, and market expansion activities.Manage all...
-
Medical Device Regulatory Compliance Manager
1 week ago
Galway, Galway, Ireland beBeeRegulatoryAffairs Full time €90,000 - €120,000Regulatory Affairs DirectorThe Regulatory Affairs Director will play a pivotal role in leading and overseeing all regulatory compliance activities for a fast-growing medical device company based in the West of Ireland. This leadership position will define and execute regulatory strategies in support of new product development and post-market activities.Key...
-
Senior Regulatory Affairs Expert
2 weeks ago
Galway, Galway, Ireland beBeeMedical Full time €100,000 - €120,000Regulatory Affairs ManagerThis critical leadership role oversees all regulatory compliance activities, defining and executing strategies for new product development and post-market activities.The ideal candidate will have a strong background in medical device regulations, including MDR, and proven ability to handle complex submissions and interactions.A...