VACANCY AT CAPGEMINI IN RA
Post: RA Specialist
A global leader in consulting, technology services and digital transformation, Capgemini is at the forefront of innovation to address the entire breadth of clients’ opportunities in the evolving world of cloud, digital and platforms.Currently they have an opening for 3 positions for RA at Capgemini, whom they would like to recruit in Capgemini, Pune.
The job description is as below:
Shall be responsible for process definition, facilitation, and implementation of Quality Management System as per ISO 13485. Support Proposal from Quality Assurance & Regulatory affairs requirements. Should be able to conduct & handle external audits programs.
5-7+ years’ experience in Medical Devices Regulatory Affairs & Quality Assurance.
• Qualified ISO 13485 Auditor, along with awareness of various harmonized standards as ISO 14971, IEC 62304, IEC 62366 & country specific regulations FDA 21 CFR 820 & EU Medical device directives.
• Develop new regulatory policies, processes and SOPs and train key personnel on them
• Evaluate regulatory risks of processes, procedures
• Provide regulatory input to product lifecycle planning
• Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes
• Utilize technical regulatory skills to propose strategies on complex issues
• Determine submission and approval requirements
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
• Assess the acceptability of quality, preclinical and clinical documentation for submission filing (PMA, 510K)
• Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions
• Compile, prepare, review and submit regulatory submission to authorities
• Monitor impact of changing regulations on submission strategies and update internal stakeholders
• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
• Provide strategic input and technical guidance on regulatory requirements to development teams
• Ensure compliance with product post marketing approval requirements
• Review and approve advertising and promotional items to ensure regulatory compliance
• Ensure external communications meet regulations
• Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events
• Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies
• Report adverse events to regulatory agencies and internal stakeholders
• Provide regulatory input for product recalls and recall communications
Interested candidates can send their updated resume at:
Placement Manager (IGMPI)
Telephone: +91 8448775080; 0120-2427175; 0120-4375280