Senior Regulatory Affairs Specialist – Co. Waterford
Role Purpose:
- Our client is looking for a Senior Global Regulatory Affairs Specialist (Medical Devices – Post Market) to join their busy site in Co. Waterford.
- The Senior Global Regulatory Affairs (GRA) Specialist will independently support all regulatory medical device initiatives for post-market/lifecycle management aspects of the company’s respective product families.
- The successful candidate is responsible for implementing the regulatory post-market strategies of all submissions for products under their responsibility, as well as managing interactions with regulatory authorities on post-market issues.
Core Duties and Responsibilities:
- Implement and manage post-market regulatory strategy for marketed devices with a focus on maximizing the business benefit balanced with regulatory compliance.
- Proactively communicate the post-market regulatory strategy, key issues, and any other critical topics throughout the post-market lifecycle to interdisciplinary project teams and to appropriate management levels in Global Regulatory Affairs, R&D, Engineering and Supply Chain, as appropriate in a timely manner.
- Lead and manage all post-market submission activities which include but are not limited to planning, compiling, authoring, reviewing, and coordinating the submission/notification.
- Make quality regulatory decisions, balancing risks and benefits.
- Identify as early as possible the required documentation and any content, quality and/or timeline issues for projects.
- Negotiate the delivery of approved technical source documents in accordance with project timelines.
- Coordinate with Regulatory Operations to ensure timely and accurate submissions to Regulatory Authorities.
- Support or manage interactions with regulatory authorities on post-market issues.
- Provide regulatory support to all departments during Regulatory Authority inspections/audits.
- Serve as a Regulatory Affairs representative on facility/site Local Change Management Boards.
- Review and provide input on regulatory authority guidance documents.
Education & Qualifications Required:
- 5+ years of Medical Device (or similar area) regulatory experience
- Knowledge of medical device industry Regulatory Affairs post-market/lifecycle management discipline, with awareness of commercialization and operations.
- 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’s and correctly apply them, as appropriate in post-approval/clearance activities.
- Demonstrated ability in analytical 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.
To Apply: Quote – PE23065
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, R95 F727, Ireland.
+353 56 77 90100
recruitment@prochem.ie
Please note, we do not require agency assistance with this role.
