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Vacancy Details


Senior Regulatory Affairs Specialist- Contract - Cork

Contract Type: Contract
Location: Cork
Date: 17/10/2018
Job Reference: 96937
Contact Name: Bimi Felix
Contact Email:

Job Description

Applicants must have a valid working visa to apply for this contract role

Contact: Caroline Kingston
Telephone: 086 8395531

Senior Regulatory Affairs Specialist- Contract

Our client a medical device company are looking to recruit a Senior Regulatory Affairs Specialist for their site in Cork on a contract basis

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
3-4 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 RA Specialist role in Cork please contact please contact Caroline Kingston on 086 8395531 /

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