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Search Results for Regulatory Affairs Manager

Job Title.	Location	Salary	Actions
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 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 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