Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Stryker

Cork, Ireland

Position Summary

  • 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.

Key Areas of Responsibility

  • 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.

Qualifications Knowledge Skills

  • 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.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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