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Search Results for Regulatory Affairs Consultant
Job Title. Location Salary Actions

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

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

Reg Affairs Specialist

Role: Regulatory Affairs Engineer Location: Parkmore, Galway (Hybrid working) Benefits: Top salary Company: My client are a growing Medical Device company who have recently moved into a high tech new site in Parkmore. They have developed an innovative new technology to improve the performance of Vascular stents. Role: Reporting to the Senior Regulatory Affairs Manager, as a Regulatory Affairs Specialist you will play a key a key role in the implementation of post-market activities within Veryan. This is a ...

Location: Connaught, Galway, Galway City, Leitrim, Limerick,
Reg 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 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 Consultant Career Profile

Regulatory Affairs Consultant


Whether it's working in a solo-operation, or in a Regulatory Consultancy, working as a consultant can give flexibility and great challenges to a Regulatory expert with a number of years in industry.

Key Responsibilities

  • Timely preparation and submission variations and renewal applications for National and MRP procedures to the IMB, MHRA and other regulatory authorities.
  • Provide responses to the competent authorities on deficiencies where they arise.
  • Review and update of summary of product characteristics and patient information leaflets as required.
  • Provide guidance and support regarding regulatory requirements as requested by clients.
  • Preparation of clinical trial submissions to various regulatory authorities.
  • Quality Control review of submission documentation prior to relevant competent authorities.
  • Perform internal audits & self-inspections to ISO 9000:2008 standard.
  • Participation in business development/marketing activities.

Skills / Experience

  • Degree minimum in a relevant area.
  • Significant experience in Regulatory setting (CRO / Medical Device / Pharma / Biotech).
  • Team player and client-focussed.