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We got a new job details in VTekis Consulting LLP & they are Hiring Candidates for Regulatory Affairs specialist / RA Specialist
Company Name : VTekis Consulting LLP
Company Location : Santa Clara, CA
Job Position : Regulatory Affairs specialist / RA Specialist
Job Category : Jobs in California
Job Description :
VTekis Consulting LLC provides complete solutions for Staff Agumentation, Recruitment Process Outsourcing, Contract Hiring, Direct Hire and Outsourced Solutions. Our goal is to deliver quality professional services to our clients not just to find someone to do a job, we match the right professional for your staffing needs and earning confidence through the proper assignment of people. This alignment of people and companies allows us to create opportunity. Most importantly, We don’t consider the process complete until we find the perfect fit.
Responsible for implementing and maintaining the effectiveness of the quality system.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Provide regulatory input to product lifecycle planning
Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
Assist in the development of multi country regulatory strategy and update strategy based upon regulatory changes
Assist in regulatory due diligence for potential and new acquisitions
Utilize technical regulatory skills to propose strategies on complex issues
Determine submission and approval requirements
Monitor trade association positions for impact on company products
Anticipate and identify regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
Recruit; develop and mentor regulatory professionals
Assess the acceptability of quality; pre-clinical and clinical documentation for submission filing
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
Monitor applications under regulatory review
Oversee processes involved with maintaining annual licenses; registrations; listings and patent information
Ensure compliance with product post marketing approval requirements
Develop; implement and manage appropriate SOPs and systems to track and manage product-associated events
Actively contribute to the development and functioning of the crisis/issue management program
Provide regulatory input for product recalls and recall communications
Report adverse events to regulatory agencies and internal stakeholders
Review and approve advertising and promotional items to ensure regulatory compliance.
Thanks and Regards,
PH – 229-264-4029.
All your information will be kept confidential according to EEO guidelines.
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