Job Title: Regulatory Affairs Specialist
We are currently recruiting for a Regulatory Affairs Specialist to join the team in Waterford of one of our large international clients, a Medical Device company.
The successful candidate will support all regulatory MCC (manufacturing changes and controls) aspects of the medical device products from a post-approval/ lifecycle-management standpoint. You will be responsible for implementing the regulatory MCC strategies of all submissions for products under your responsibility, as well as managing interactions with regulatory authorities on MCC issues.
This is an exciting opportunity to gain experience in a highly regulated environment where you will have one to one mentoring and continued support throughout.
- Implement and drive MCC regulatory strategy for marketed devices with a focus on maximizing the business benefit balanced with regulatory compliance.
- Proactively communicate MCC regulatory strategy, key issues and any other critical topics throughout the post-market life cycle to interdisciplinary project teams and to appropriate management levels in Global Regulatory Affairs, R&D, TechOps and Supply Chain, as appropriate in a timely manner.
- Lead and drive all MCC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Make quality regulatory decisions, balancing risks and benefits.
- Identify as early as possible, the required documentation and any content, quality and/or time-line issues. Negotiate the delivery of approved technical source documents in accordance with project time-lines.
- Provide regulatory support to other departments during Regulatory Authority inspections.
- Serve as a Regulatory Affairs representative on facility/site Local Change Management Boards.
- Review and provide input on proposed health or regulatory authority guidance documents on MCC issues.
- Knowledge of medical device industry Regulatory Affairs post-market/life cycle management (MCC) discipline, with awareness of commercialization and operations an advantage.
- Capability to react quickly to changes in the regulatory environment and make strategic recommendations to minimize risk to the business.
- Ability to interpret Regulatory Authority policies and guidance and correctly apply them, as appropriate in post-approval/clearance activities.
- Demonstrated ability in analytic reasoning and critical thinking skills.
- Strong capability to contribute to a team environment.
- Excellent communication skills; both oral and written.
- Self-motivated, detail-oriented, and capable of working independently.
Kelly Services are acting as an Employment Business in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.