Hot Regulatory Affairs Jobs

Blood Tissue and Organ Inspector

Blood Tissue and Organ Inspector Our client, a large regulatory body, are currently recruiting for a Blood Tissue and Organ Inspector to join their team. As Blood Tissue and Organ Inspector you will be responsible for assessing the compliance of organ procurement centres, organ transplant centres, blood establishments and tissue establishments with the requirements of European and National legislation and associated good practice guidelines. The role of an Inspector is to evaluate the compliance of sites inspected, in Ireland and abroad, with the requirements of National legi...

Location: Dublin,

Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to the Senior Reg...

Location: Athlone, Clare, Connaught, Galway, Galway City,

CMC Pre-Approval Regulatory Scientist

CMC Pre-Approval Regulatory Scientist Our client, a global pharma company, are currently recruiting for a CMC Pre-Approval Regulatory Scientist to join their team on a permanent basis. This is an excellent opportunity to join a global team very strong of regulatory experts.. As CMC Pre-Approval Regulatory Scientist, you will partner with Global Regulatory Affairs – CMC (GRA-CMC) Regulatory Scientists to provide strategic, tactical and operational direction and support to expedite CMC development of the organisations portfolio by developing successful regul...

Location: Cork,

Senior R&D Manager - Lifecycle Management

Job title: Senior R&D Manager, Lifecycle Management Location: Ballybrit, Galway Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are a Medical Device company who have recently been acquired by a multinational, a global leader in neurovascular care. And a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.My client invests in their people, and ta...

Location: Galway, Galway City,

Regulatory Affairs Manager

Regulatory Affairs Manager Our client, a pharma organisation, are currently recruiting for a Regulatory Affairs Manager to join their team on a permanent basis with hybrid working. Experience working with oral solid dosage (OSD) forms is essential for this role. You will work with a small team in Ireland and other team members across the UK and EU. Responsibilities Advise and liaise services on behalf of company to ensure that requirements of national competent authorities are met Create, assemble, review and publish regulatory submissions in accordance with agreed ...

Location: Dublin,

CMC Regulatory Senior Scientist

CMC Regulatory Senior Scientist Our client, a global pharma company, are currently recruiting for a CMC Regulatory Senior Scientist to join their team on a permanent basis. This is an excellent opportunity to join a global team very strong of regulatory experts. This role offers hybrid working. As CMC Regulatory Senior Scientist, you will lead various aspects of the global marketing authorization submission management processes, help manage submission content for Drug Substance and Drug Product, provide guidance on structure and content placement within CTD registration submissi...

Location: Cork,

Regulatory Affairs - Complaints Co-Ordinator

AMC0010 Regulatory Affairs - Complaint Co-ordinator 6 month contract Hybrid - Dublin - D12 Product Complaints Coordinator Role Main tasks: Management of product complaints for products on the Irish market, from initial receipt through to closure, in conjunction with the company’s Global Complaints Departments and in accordance with all relevant EU legislation, HPRA Guidelines and company specific Standard Operating Procedures. Document and maintain the complaint files for reports received. Prompt communicati...

Location: Dublin,

Senior Reg Affairs Specialist - Post Market

Job title: Senior Regulatory Affairs Specialist – Post market Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to t...

Location: Galway, Galway City,

Qualified Person

Qualified Person Our client, a global biotech,are seeking a highly motivated and detail-oriented Qualified Person to join the quality assurance team as the Lead QP onsite. The successful candidate will have previously been a named QP on a Irish licence previously. Responsibilities Ensure manufactured biotech drug substance (DS) batches are certified in accordance with all required regulations and in compliance with IND/CTAs/ manufacturing authorisation/ marketing authorisation Ensure that biotech drug product batches are test...

Location: Limerick, Limerick City,

Quality Systems Enginer

Role: Quality Systems Engineer 24 month ftc with strong chance of going permanent. Based in Dun Laoghaire – on site role Competitive salary, Healthcare, bonus or share options. Pension contribution from company after 24 months. Job Purpose: Reporting to the Quality Systems Manager, duties will include implementing & maintaining the Company’s Quality Management System in accordance with applicable standards and regulations Responsibilities: Be a key driver of cGMP practices within Operations and Quality divisions Act as a p...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,

Quality Manager

Job title: Quality Engineer/ Quality Manager Location: ATU Ihub, Galway Company: My client are a developer of innovative medical devices which transform the mobility and quality of life of enteral feeding users. Their team understands that current feeding systems are complex, inconvenient and a burden on users’ daily lives. My client have developed the Mobility+® the first of its kind FDA cleared Elastomeric enteral feeding system. The Mobility+® is now available in the US market and has FDA Approval. Overview: As a Quality Engi...

Location: Clare, Galway, Galway City, Limerick, Limerick City,

Quality Systems Manager

Company: My client are have a global portfolio which includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. They are committed to helping create healthier communities worldwide through education, outreach and better access to treatment Role: Quality Systems Manager - Senior Location: Newenham Court, Northern Cross, Malahide rd, Dublin 17 Team: 6 direct reports Hybrid working: 2-3 days a week on site per week Benefits: Compe...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,

Senior Regulatroy Affairs Specialsit

Senior Regulatory Specialist Our client a well funded high potential medical device start up are currently seeking experienced regulatory professional top join their team. The Senior Regulatory Affairs Specialist will work closely with a cross-functional team to obtain the regulatory approvals/clearances needed to support clinical and commercial use of an innovative new therapy. Role/Responsibilities Support and advise the VP Quality and Regulatory Affairs by executing regulatory activities and developing regulatory strategies to support...

Location: Galway,

Regulatory Affairs Specialist

Regulatory Affairs Specialist (Remote/Hybrid) Our client a high potential start up medical device company currently seeks a Regulatory Affairs Specialist to join their team. Reporting to the Clinical and Regulatory Affairs Manager, the Regulatory Specialist will be responsible for helping with compliance to standards, regulatory submissions and annual reporting to the notified body and FDA. The Regulatory Affairs Specialist must have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry. This position re...

Location: Cork,

Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist Our client a Medical Device Multinational currently seeks a Senior Regulatory Specialist to join their team. The Senior. Regulatory Affairs Specialist will develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction. The Sr. Regulatory position will assist in mentoring and development of staff members as part of the role. Role/Responsibilities • Manage Technical Documentation ...

Location: Westmeath,