Regulatory And Compliance Manager

R.T.Lane Recruiting Talent

Waterford

Are you interested in Global opportunities in Regulatory and Compliance? A great opportunity has presented in Waterford with a Medical Devices company looking for someone to manage the Reg and Compliance function on a Global scale. Please get in touch TODAY to discss this opportunity with Rachel Lane on 022 46969 or email rachel@rtlanerecruitment.ie for details. Role: 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 contact lens 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. Qualifications and Requirements: Minimum Bachelor’s Degree BS in engineering or scientific discipline (Chemistry, Biology, Microbiology or related technical field. 3-5 years’ experience in Regulatory Affairs is necessary. Knowledge of FDA & EU regulatory requirements necessary. Other regional RA requirement knowledge an advantage. This job originally appeared on RecruitIreland.com.

2345 days ago