Regulatory Affairs Associate

Preferred candidate profileQualifications/ JD:Bachelor's degree in Mechanical / Biomedical / SW /HW Engineering, Quality Assurance, Regulatory Affairs, or a related field.In-depth understanding of medical device regulations, including FDA 21 CFR Part and ISO 13485:2016 requirements for design controls and DHF.Experience with risk management principles (e.g.,...

Job Description Experience: 2 to 5 years Education: Bachelor's degree in Biomedical, Mechanical, or B.Pharm We are looking for talented professionals for roles in Quality Assurance, Regulatory Affairs, and Documentation in the Medical Devices domain. Skills & Requirements: Minimum 3 years of experience in Medical Devices Regulatory Affairs, Quality...

A Medical Affairs Manager will develop and execute medical strategies, ensuring scientific and regulatory compliance, and serving as a medical expert for internal and external stakeholders.About the RoleKey responsibilities involve managing clinical trial activities, creating and approving promotional materials, and building relationships with healthcare...

Looking for Immediate joiners - From 3+ to 10 yrs :-Key responsibilitiesValidation Gap Analysis: Conduct comprehensive gap analyses of existing IQ, OQ, and PQ documentation, protocols, and processes against regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485) and industry best practices.Deviation Investigation and Resolution: Investigate deviations...

Looking for Immediate joiners - From 3+ to 10 yrs :-Key responsibilitiesValidation Gap Analysis: Conduct comprehensive gap analyses of existing IQ, OQ, and PQ documentation, protocols, and processes against regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485) and industry best practices.Deviation Investigation and Resolution: Investigate deviations...

Looking for Immediate joiners - From 3+ to 10 yrs :-Key responsibilitiesValidation Gap Analysis: Conduct comprehensive gap analyses of existing IQ, OQ, and PQ documentation, protocols, and processes against regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485) and industry best practices.Deviation Investigation and Resolution: Investigate deviations...

Looking for Immediate joiners - From 3+ to 10 yrs :-Key responsibilitiesValidation Gap Analysis: Conduct comprehensive gap analyses of existing IQ, OQ, and PQ documentation, protocols, and processes against regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485) and industry best practices.Deviation Investigation and Resolution: Investigate deviations...

Looking for Immediate joiners - From 3+ to 10 yrs :-Key responsibilities Validation Gap Analysis: Conduct comprehensive gap analyses of existing IQ, OQ, and PQ documentation, protocols, and processes against regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485) and industry best practices. Deviation Investigation and Resolution: Investigate...

Looking for Immediate joiners - From 3+ to 10 yrs :- Key responsibilities Validation Gap Analysis : Conduct comprehensive gap analyses of existing IQ, OQ, and PQ documentation, protocols, and processes against regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485) and industry best practices. Deviation Investigation and Resolution : Investigate...

Looking for Immediate joiners - From 3+ to 10 yrs :- Key responsibilities Validation Gap Analysis: Conduct comprehensive gap analyses of existing IQ, OQ, and PQ documentation, protocols, and processes against regulatory requirements (e.G., FDA 21 CFR Part 820, ISO 13485) and industry best practices. Deviation Investigation and Resolution: Investigate...