Regulatory Compliance Manager
Are you an experienced Regulatory Compliance Professional looking for a fantastic new opportunity?
My client is looking for you to join their team based in Waterford!
About The Company:
Your new employer is a multinational and leading manufacturer of health products. Their impressive Waterford site has evolved since establishment over 30 years ago to become a world-class facility with cutting-edge technology and a dedicated, supportive team. Your hard work will pay off as there is a culture here of promoting from within.
Purpose of the Role:
* Quality oversight of Change Management
* Regulatory support for regional RA
* Strategic direction for regulatory requirements FDA & ISO 13485 including MDR introduction
* The role will include the following activities with respect to implementation of new standards & regulations
* Determine impact & identify appropriate implementation activities required to implement new regulations & standards in relation to operations globally
* Help solidify and strengthen the Global regulatory support network and process through proactive engagement with international peers and key stakeholders
* Provide single point of contact for the regional informational requests for registration support and country specific requirements
* Represent Regulatory Affairs on project/product development teams and identifying the regulatory strategy for these activities
* Responsible for the development of global regulatory strategies for contact lenses based on US FDA regulations, European Medical Device * Directive, External Standards, and other international regulations
* Minimum Bachelor's Degree BS in engineering or scientific discipline (Chemistry, Biology, Microbiology or related technical field)
* 3-5 years' experience in Regulatory Affairs essential.
* Strong knowledge of FDA & EU regulatory requirements essential
* Other regional RA requirement knowledge an advantage
What you'll get in return:
You will receive competitive salary plus bonus, very generous holiday allowance, pension and VHI healthcare
This is a superb opportunity to work in a cutting-edge manufacturing environment where the demands are great but where there is ample opportunity to progress your career with an employer that puts a premium on talent development and employee engagement.
Based in Waterford, Ireland this job is easily commutable to Cork, Tipperary, Kilkenny or Wexford.
What you need to do now:
Apply today: click the button!
Have some questions about the job or want to have a chat?
Call Leo on 086 049 5443 or connect with me on http://bit.ly/2tm1My2 or https://twitter.com/LeoRecruits