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Senior RA Specialist

Job Title: Senior RA Specialist
Contract Type: Contract
Location: Cork
REF: 85540
Job Published: about 2 years ago

Job Description

Principal Regulatory Affairs Specialist

Our client, a leading medical device company requires an experienced RA Specialist for a job in Cork.

This role will involve developing global regulatory strategies, authoring regulatory submissions, interacting with regulatory agencies/notified bodies, reviewing labelling, and evaluating proposed device changes.

Key Responsibilities:
  • Assist Management in training RA Specialists & Sr. RA Specialists as required.
  • Author and update divisional SOPs, recommend timely changes to ensure regulatory compliance, and lead process improvements to maximize efficiencies
  • Possess and apply a broad knowledge and understanding of the regulatory and legal frameworks, processes, and procedures to bring products to market and maintain compliance
  • Author FDA submissions, EU design dossiers, and other regulatory documents to obtain approval for products on market.
  • Partner with global regulatory affiliates and leverage Reconstructive product expertise to provide submission documentation for expedited international market access and sustaining support.
  • Assess global impact of changes to launched products and support notifications/submissions as required.
  • Review labelling for compliance with regulatory requirements.
  • Preparing and updating US product registrations and listings
  • Ensuring compliance with product post-market or clearance requirements (progress reports, annual reports etc.)
  • Assessing the acceptability of quality, preclinical and clinical documentation for submission to comply with regulatory requirements
  • Leading process improvement activities and projects.
  • Leading complex projects and mentoring less experienced RA team members in the execution of tasks as required.
  • Expand knowledge of regulatory guidelines and disseminate information, requirements, and precedents
  • Manage and lead RA projects of broader and complex/strategic nature
  • Assess necessary changes through the Regulatory Assessment process and the assess the impact cumulative changes

Education, Experience and Skills:
  • Degree in Science or Engineering or equivalent required
  • RAC Certification or Degree in Regulatory Affairs preferable
  • Minimum 4-7 years? regulatory experience in the medical device or pharmaceutical industry
  • 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 understand and explain detailed regulatory compliance programs and/or issues.
  • Ability to assess changes and identify impact to entire quality system
  • Ability to communicate and network with regulatory personnel to obtain relevant information
  • Ability to negotiate with FDA, Notified bodies and other Competent Authorities
  • Excellent analytical, writing, and problem solving skills
  • Excellent interpersonal, oral, and written communications skills.
  • Strong project management capabilities
  • Plans, conducts and supervises assignments
  • Technical leadership in providing guidance, training, and mentoring to less experienced colleagues and cross-functional team members.

For further information on this Principal Regulatory Affairs Specialist role in Cork please contact Cliona O?Malley on 091730022 /
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