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Job Title.	Location	Salary	Actions
Global Labelling Technical Regulatory Affairs Lead (Associate Director) Global Labelling Technical Regulatory Affairs Lead (Associate Director) Our client is a global healthcare leader with employees around the world who work to discover and bring life-changing medicines to those who need them. Their office in Cork consists of a talented diverse team of over 2,000 employees across 60 nationalities who deliver innovative solutions that add value across a variety ofBusiness Service functions including Medical, Clinical Trials, Finance, Information Technology and more. They provide a premium workspace across our ca... Location: Cork, Global Labelling Technical Regulatory Affairs Lead (Associate Director)	Cork	Not Disclosed
Senior Director Global Regulatory Lead Early Clinical Development Senior Director Global Regulatory Lead Early Clinical Development Our client, a global pharma company, are currently recruiting for a Senior Director Global Regulatory Lead Early Clinical Development to joint their team on a permanent basis. As Senior Director Global Regulatory Lead Early Clinical Development you will be the regulatory regional lead for assigned molecules in development. You will be responsible for driving the regulatory strategy for development in the US and Canada from discovery through the start of registration studies. You will partner with other global... Location: Cork, Senior Director Global Regulatory Lead Early Clinical Development	Cork	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 Director Career Profile

Regulatory Affairs Director

A strategic role which is responsible for the overall direction of the company, often involved in a smaller company at start-up stage. The spec below refers to an example position in the Medical Device sector

Key Responsibilities

Compliance with and adherence to medical device regulations in the geographical areas mentioned.
Achieve approval for these 2 products to be sold in new territories, in accordance with Class III Medical Device regulations.
Introduce and managed design control and quality systems.
Regular meetings with other territories, to collaborate on solutions and current progress. Included in this will be frequent air travel.
Dealing directly with relevant local regulatory bodies.
Managed Customer Complaints though extensive consultation with physicians and Sales and Marketing personnel.
Assisting with research and seeking regulatory approval in relation to possible other clinical indications of the products in various markets.
Authored and deliver product presentations to physicians and to sales personnel.
Liaise with international colleagues in relation to ongoing clinical monitoring.

Skills / Experience

B.Sc. degree in Life Sciences, advanced degree preferred.
10+ years experience in Medical Device Regulatory Affairs, specifically dealing with emerging geographical markets. 4 years in a senior management capacity, preferably internationally.
Knowledge of GI / urinary diseases.

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Regulatory Affairs Director Career Profile

Regulatory Affairs Director