Our client, a medical device company in Galway is currently looking to recruit a Regulatory Affairs Specialist for their site on a fixed term basis
In summary the job will involve the following: Plan, organize and implement strategies and activities required to ensure compliance to all US, EU and Company international requirements and corporate policies and procedures regarding submissions and other requirements for market approval of medical device products. Participate in cross functional team activities from initial stages through securing approvals.
The occupant will have expertise in areas that include
- Preparation of dossiers for product registrations outside the U.S.
- Preparation of submissions to the U.S. FDA
- Sufficient technical expertise to understand regulatory impact re. safety and efficacy of proposed manufacturing changes
- Monitoring of regulatory changes for impact to site quality system
- Participate in site internal compliance program
- Preparation for external audits
- Manages FDA regulatory submission process, including authoring submissions as applicable for ZOML changes/Transfers.
- Oversees the development of dossiers for registration of products in countries outside the U.S, including authoring submissions.
- Provides ongoing input to value improvement engineering teams on possible regulatory impact of proposed changes.
- Applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization.
- Co-ordinate Change Notification for EU Design Dossier related to ZOML changes/Transfers.
- Establish and maintain regulatory information systems both electronically and hard copy.
- Demonstrated strong writing and communication skills.
- Strong attention to details, and ability to multitask.
- Understands the overall business environment, the orthopaedic industry and the marketplace.
- Background in manufacturing with the ability to learn manufacturing processes.
- Mastery of relevant regulations, and ability to stay abreast of regulations pertinent to medical devices.
- Ability to function well as a member of the team and build relationships between RA and other areas of the organization.
- Strong computer skills.
- Able to identify and assess business risks for a given Regulatory strategy.
Education/ Experience Requirements
- Bachelor’s Degree (4-year university degree) life sciences, technical (engineering), quality or related field.
- 3 years’ experience in a regulatory position. Regulatory background should include the medical device area.
- A combination of education and experience may be considered.
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