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Search Results for Regulatory Affairs Officer

Job Title.	Location	Salary	Actions
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 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

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Regulatory Affairs Officer Career Profile

Regulatory Affairs Officer

The Regulatory Affairs (RA) department is tasked with ensuring that the company complies with all of the local and international regulations and laws pertaining to their business. The Regulatory Affairs Officer works with international, state and local regulatory agencies, such as the Irish Medicines Board (IMB), the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) on specific issues affecting their business. The Regulatory Affairs Officer advises the company on the current regulatory aspects and climate that would affect proposed activities. The RA Officer has many interactions within the medical affairs dept. including medical information, pharmacovigilance and clinical trials.

Key responsibilities of the Regulatory Affairs Officer

Maintenance of Irish and overseas licenses including preparation of variation and renewal applications as appropriate.
Preparation and submission of Marketing Authorisation applications to EU regulatory authorities.
Preparation of dossiers to obtain CE marking for medical devices.
Ensuring Labelling complies with appropriate legislation.
Ensure approved regulatory requirements are enforced in-house.
Participate in the development of electronic submission of dossiers.
Provide support to R&D projects; including new product introductions, changes to existing products and processes.
Liaise with suppliers, clients, development partners and regulatory bodies.
Ensure guidelines and knowledge of legislation is current and be able to advise of future developments and changes.
Monitor the process of regulatory submissions, responding to queries and ensuring that registration approvals are granted without undue delay.

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