Years’Experience: Must have 3-5 years of experiences in Medical Device Regulatory Affairs
Job responsibilities:-
Compile, prepare, and review regulatory submission to US and EU.
Anticipate regulatory obstacles and emerging issues throughout the product submission cycle and develop solutions with other members of regulatory and related teams
Provide regulatory input for responsible countries/region for product lifecycle planning
Monitor applications under regulatory review, and communicate application progress to internal stakeholders
Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
Utilize technical regulatory skills to propose strategies on complex issues
Identify emerging issues for responsible countries/region
Assess the acceptability of quality, preclinical and clinical documentation for submission filing
Provide registration impact assessment in responsible countries/region for design changes
Provide strategic input and technical guidance on regulatory requirements to development teams
Ensure external communications for regulatory purposes meet regulations
If you're interested in this opportunity, please share your updated resume with us at vamsi@intellectt.com or call +1 732-380-6013.
Seniority level
Associate
Employment type
Contract
Job function
Legal
Industries
Biotechnology Research, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing
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