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Hot Regulatory Affairs Jobs

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Search Results for Regulatory Affairs Manager

Job Title.	Location	Salary	Actions
Senior Audit & Compliance Specialist Senior Audit & Compliance Specialist This senior position sits within a global healthcare leader’s high-growth Diagnostics business unit. Reporting to the Audit & Inspection Readiness Manager, the successful candidate will lead the supplier audit lifecycle and maintain a state of continuous inspection readiness across multi-site manufacturing networks. Key Responsibilities Audit Lifecycle Leadership: Independently plan, execute, and report on global supplier, internal, and external quality system audits. Compliance: Ensure all Quality... Location: Galway, Senior Audit & Compliance Specialist	Galway	Not Disclosed
Quality and Regulatory Affairs Manager Quality & Regulatory Affairs Manager Location: Dublin, Ireland (Hybrid) Type: Full-Time About the Opportunity An innovative and rapidly growing medical device company is seeking an experienced Quality & Regulatory Affairs Manager to lead quality and regulatory activities as the organisation progresses through post-market clinical activities and prepares for commercial expansion in the United States and Europe. This is an exciting opportunity to join a high-growth MedTech business that has achieved FDA clearance for its first technology indication and i... Location: Dublin, Quality and Regulatory Affairs Manager	Dublin	Not Disclosed
Quality Manager Title: QA / RA Manager Location: ATU Ihub, Dublin Road, Galway Company: My client are a Medical are an early-stage start-up focused on developing patient solutions in the area of palliative care. Their initial technology platform is a catheter-based device used to treat the build-up of fluid in the body. Role: QARA Manager with DA focus on a 9-month contract basis who will thrive in a multidisciplinary start-up environment. Looking for people that are curious, have a similar strong work ethic to our own, and are motivated by the positive influe... Location: Galway, Galway City, Quality Manager	Galway	Not Disclosed
Quality Manager Title: QA / RA Manager Location: ATU Ihub, Dublin Road, Galway Company: My client are a Medical are an early-stage start-up focused on developing patient solutions in the area of palliative care. Their initial technology platform is a catheter-based device used to treat the build-up of fluid in the body. Role: QARA Manager with DA focus on a 9-month contract basis who will thrive in a multidisciplinary start-up environment. Looking for people that are curious, have a similar strong work ethic to our own, and are motivated by the positive influe... Location: Galway, Galway City, Quality Manager	Galway	Not Disclosed
Quality Manager Title: QA / RA Manager Location: ATU Ihub, Dublin Road, Galway Company: My client are a Medical are an early-stage start-up focused on developing patient solutions in the area of palliative care. Their initial technology platform is a catheter-based device used to treat the build-up of fluid in the body. Role: QARA Manager with DA focus on a 9-month contract basis who will thrive in a multidisciplinary start-up environment. Looking for people that are curious, have a similar strong work ethic to our own, and are motivated by the positive influe... Location: Galway, Galway City, Quality Manager	Galway	Not Disclosed
Regulatory Affairs Manager- Remote JOB DESCRIPTION Regulatory Affairs Manager – Medical Devices Location: Ireland (Remote) Reports To: CEO / Founder Employment: Full-time, Permanent Start Date: ASAP About the Company The company is a vertically integrated manufacturer of precision medical device components with international operations. It designs, machines, coats, and packages high-specification titanium components for the global medical device market. The organisation is building its regulatory function from the ground up. This is a foundational hire where you will own the ... Location: Republic of Ireland, Regulatory Affairs Manager- Remote	Republic of Ireland	Not Disclosed
Director of Regulatory Affairs Director of Regulatory Affairs 📍 Galway, Ireland (Hybrid) Lead Regulatory Strategy in a High-Growth MedTech Environment An innovative, growth-stage medical device company based in Galway is seeking an experienced Director of Regulatory Affairs to lead global regulatory strategy and compliance activities. This is a senior leadership opportunity within a dynamic SME environment, offering the chance to shape regulatory direction while partnering closely with executive leadership and cross-functional teams. The Opportunity Reporting to the executive team%... Location: Galway, Director of Regulatory Affairs	Galway	Not Disclosed
Senior Regulatory Affairs Manager Job title: Sr Regulatory Affairs Manager Location: Mervue, Galway Benefits: Top salary, bonus, pension, healthcare and car allowance Overview: As the Senior Manager of Regulatory Affairs, you play a key leadership role within the Acute Care & Monitoring (ACM) operating unit, supporting regulatory activities for a portfolio of products. This role entails implementing regulatory strategies, managing regulatory submissions, assessing the regulatory impact of product changes, and ensuring your team delivers high-quality results ... Location: Galway, Galway City, Senior Regulatory Affairs Manager	Galway	Not Disclosed
Regulatory Affairs Manager - Senior Job title: Sr Regulatory Affairs Manager Location: Mervue, Galway Benefits: Top salary, bonus, pension, healthcare and car allowance Overview: As the Senior Manager of Regulatory Affairs, you play a key leadership role within the Acute Care & Monitoring (ACM) operating unit, supporting regulatory activities for a portfolio of products. This role entails implementing regulatory strategies, managing regulatory submissions, assessing the regulatory impact of product changes, and ensuring your team delivers high-quality results... Location: Galway, Galway City, Regulatory Affairs Manager - Senior	Galway	Not Disclosed
Regulatory Affairs Maanger Regulatory Affairs Manager Our client a fast-growing medical device company based in the West of Ireland, dedicated to transforming outcomes for patients are seeking a highly motivated Regulatory Affairs Manager to lead and oversee all regulatory compliance activities. This critical leadership role will define and execute regulatory strategies in support of both new product development and post-market activities. Role/Responsibilities Lead the regulatory strategy for new product introductions and support existing products through their full lifecycle. Mana... Location: Galway, Regulatory Affairs Maanger	Galway	Not Disclosed
Senior Regulatory Affairs Specialist Job title: Senior Regulatory Affairs Specialist Location: Parkmore, Galway. 1 day 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 Se... Location: Athlone, Clare, Connaught, Galway, Galway City, Senior Regulatory Affairs Specialist	EU	Not Disclosed
Senior Regulatory Affairs Specialist Job title: Senior Regulatory Affairs Specialist Location: Parkmore, Galway. 1 day 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 Se... Location: Athlone, Clare, Connaught, Galway, Galway City, Senior Regulatory Affairs Specialist	EU	Not Disclosed
Senior Regulatory Affairs Specialist Job title: Senior Regulatory Affairs Specialist Location: Parkmore, Galway. 1 day 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 Se... Location: Athlone, Clare, Connaught, Galway, Galway City, Senior Regulatory Affairs Specialist	EU	Not Disclosed
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, Senior Regulatory Affairs Specialist	EU	Not Disclosed
Senior Regulatory Affairs Specialist 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. Rep... Location: Athlone, Clare, Connaught, Galway, Galway City, Senior Regulatory Affairs Specialist	EU	Not Disclosed
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, Senior Reg Affairs Specialist - Post Market	Galway	Not Disclosed
Senior Regulatory Affairs Specialist Job title: Senior Regulatory Affairs Specialist – Premarket Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Company: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. This role is best suited to an individual who is self-motivated, accountable and seeking infinite learning and growth opportunities. Role: As a Senior Regulatory Affairs Specialist you will will pl... Location: Clare, Connaught, Galway, Galway City, Limerick, Senior Regulatory Affairs Specialist	EU	Not Disclosed

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Regulatory Affairs Manager Career Profile

Regulatory Affairs Manager

This role is normally suited to someone with a minimum of 5 years in a Regulatory setting, ideally more. Management, departmental budgeting, training are some of the keys tasks involved on the non-technical side of the role.

Key Responsibilities

Coordinating, compiling and submitting Marketing Authorisation variations for existing approvals
Composing and reviewing Pre-IND information packages and NDA packages for registration of prescription products in the US through the FDA
Liaise with partner companies as the primary Regulatory Affairs contact for the company to achieve product registration in all new worldwide regions within projected timeframes
Regulatory Affairs European project team leader for all new projects
Interpreting EU and US regulatory guidelines and procedures and ensuring the regulatory compliance of the company in all new regions Establish and analyse department budget
Identify and recommend areas for cost savings from and Regulatory and compliance perspective
Provide Regulatory advice and feedback for all internal company departments and external partners
Maintain and apply a high level of awareness and understanding of the impact of existing and future planned regulations

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Regulatory Affairs Manager Career Profile

Regulatory Affairs Manager