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.
- 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 / firstname.lastname@example.org
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