Regulatory Affairs Manager
Our client is an established medical device company based in Galway. They are looking to hire the services of a Regulatory Affairs Manager to join an existing team reporting to the RA Director.
Medical Device manufacturer – class III & combination device products. Our client is growing and have created a new position within their regulatory and quality team for a Regulatory Affairs Manager.
This is an excellent time to be joining a well invested, established and growing medical device company within a progressive role. Please apply today for more information.
Galway – Southern Ireland
Regulatory Affairs Manager / RA Manager
Circa €80,000 per annum plus bonus, healthcare, pension. Applicants seeking more or less will also be considered depending on experience
Our client is looking for someone who can focus on managing global regulatory submissions including preparation of a PMA. In addition, this role will have responsibilities that include;
- CE Marking / IDE Submissions
- Technical File submissions
- EU Substantial Change Notifications,
- EU Clinical Evaluation Reports
- Post market surveillance reporting
- Compilation and review of regulatory documentations to support global pre & post market clinical study submissions
- Review product labelling changes, change control and non-confirming process
- Provision of regulatory oversight of clinical operations
- Advise on regulatory strategy Implementing regulatory requirements in accordance of ISO 13485, MDD, MDR
Our client is looking for a freelance RA Manager with fully up to date medical device expertise – the ideal applicant will have a combination of the following skills / experience;
- Previous experience of combination medical devices – highly sought after
- Experience of class III medical device regulations – ideally
- Experience within Vascular / Cardiovascular medical devices – highly advantageous
- Experience of PMA submissions
- Experience of FDA / 510(K) submissions
- Experience of clinical evidence – background within research / scientific background – ideally
- Up to date knowledge of MDD / MDR
Indo Professionals is a staffing specialist to the medical device industry. We focus on finding positions within regulatory, quality and clinical research. We work with our job seekers on a project basis, providing one to one consultation and up to the minute market information. Please contact the team today.