Telephone: 086 8395533
Senior Reg Affairs Specialist
Our client, a medical device company in Cork is currently looking to recruit a Senior Reg Affairs Specialist for their site.
Job Description / Information
- Supports new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes.
- Supports the product lifecycle through to obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance.
- Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies.
- Viewed as regulatory team resource.
- Developing and applying basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures
- Assisting in SOP development and review
- Assisting in the development and update of regulatory strategy based upon regulatory changes
- Providing regulatory input to new product development and product lifecycle planning
- Evaluating regulatory impact of proposed changes to launched products
- Demonstrating understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications
- Determining and communicating submission and approval requirements
- Participating in risk-benefit analysis for regulatory compliance
- Continuing to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
- Maintaining annual licenses, registrations, and listings
- Ensuring compliance with product post-approval or clearance requirements
- Approving labelling, advertising and promotional items for compliance before release
- Reviewing publicly disseminated information to minimize regulatory exposure
- Reviewing product claims and preserving confidentiality of applicable product information
- Providing regulatory input for and appropriate follow-up to inspections and audits
- Reviewing change management to determine the level of change and potential submission requirements
- Identifying product-associated problems and developing proposals for solutions
- Advising responsible personnel on regulatory requirements for quality, preclinical and clinical data requirements for clinical study applications or marketing applications
- Evaluating proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
- Assessing the acceptability of quality, preclinical and clinical documentation for submission to comply with regulatory requirements
- Monitoring impact of changing regulations on submission strategies
- Identifying issues early in the submission preparation process that could impact product launch
- Compiling, preparing, reviewing and submitting regulatory dossiers to authorities
- Participating in negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance
- Ability to contribute to the resolution of routine regulatory issues using sound judgment
- Ability to understand and explain detailed regulatory compliance programs and/or issues
- Ability to comply with constantly changing regulatory procedures and prioritize work effectively
- Ability to communicate and network with regulatory personnel to obtain relevant information
- B.Sc. in Engineering, Sciences or equivalent preferred
- 1-3 years regulatory experience in the medical device or pharmaceutical industry
- RAC certification (preferred)
- Knowledge of the Quality System Regulations (21 CFR), Medical Device Directives (MDD) and MEDDEV guidance
- Knowledge of other regulations related to Pre Market Clearance and Post Market Support
- Ability to work with cross functional teams
- Ability to plan and conduct meetings
- Ability to negotiate internally and externally with FDA, NB and other regulatory bodies
- Excellent analytical and writing skills
- Effective organizational skills
For further information on this Senior Reg Affairs Specialist role in Cork please contact Bimi Felix on 086 8395533 / email@example.com
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