An excellent opportunity for a Senior Regulatory Affairs Specialist to join a Global Medical Devices company in Ireland. This position will join a brand new team with exciting growth & progression potential. Our client is a prominent global provider of specialized medical technologies, dedicated to enhancing patient and provider safety and improving healthcare outcomes. The Senior Regulatory Affairs Specialist will play a crucial role in supporting material cost improvement (MCI) initiatives to reduce costs and enhance product margins. This role involves developing regulatory strategies and submissions and collaborating with commercial teams and other regulatory functions to align projects with business objectives.
This position is a Hybrid based opportunity.
Onsite location is Athlone.
Leadership in Regulatory Affairs (RA):Act as the lead in Regulatory Affairs within the team, driving Material CIP programs forward.Collaborate with cross-functional RA peers to establish key risks and craft program implementation plans.
Regulatory Support and Compliance: Provide regulatory support for Material CIP projects, offering input and approval for new supplier changes. Identify critical risks associated with Material CIP programs and communicate them effectively to the Program Lead to ensure comprehensive capture of regulatory impacts in each project.
Project Planning and Management: Support the Program Lead in developing Regulatory Affairs timelines aligned with project charters and implementation plans.
Documentation Management: Manage technical documentation related to regulatory compliance. Conduct global regulatory impact assessments.
Change Control and Compliance: Review and assess change control activities for their potential impact on current regulatory filings.Ensure full compliance of operations with license details and updates in accordance with relevant guidelines and directives.
Stakeholder Communication: Manage stakeholder communication effectively to ensure the transparent dissemination of project status and related issues.
Qualifications Experience Required:
5 years of working within R&D/QA/RA in a medical device environment is preferred
Minimum of 3 years experience in R&D, QA/RA, Validations essential
3/4 years experience in Risk, Clinical and Biocompatibility an advantage
Excellent technical writing experience within a medical device environment essential
Attention to detail and accuracy essential
Fluent in English, both written and oral essential
Ability to work well under deadlines and pressure
Problem solving skills for developing creative solutions and meeting objectives are required.
For a confidential discussion and more information on the role contact Gillian Nicholson
+353 90 6450665