SENIOR REG AFFAIRS SPECIALIST required by CareerWise for our multinational medical device client at the R&D Innovation Centre in Cork, 16 month Fixed Term Contract on offer.
The SENIOR REG AFFAIRS SPECIALIST will support new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes.
Role of this position
- 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.
- 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.
Please call Conor Twomey today for further information on 021 4297422 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)