Regulatory Affairs Specialist

2 weeks ago

Mumbai, Maharashtra, India Randstad Digital Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Job Title: Sr. Regulatory Specialist

Location: Pune/Bangalore

Experience:5-8Years

Job Description:

As the Sr. Regulatory Specialist, this position will:

Must Have:(SaMD product experience)

Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices.

Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance.

Assist in SOP development and review in support of "next-gen" product offerings.

Revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.

Understand and investigate regulatory history/background of class, disease/ therapeutic context in order to assess regulatory implications for approval.

Create and ensure maintenance of technical documentation (such as clinical evaluation reports, risk management reports, 510(k) notification) as required for obtaining and/or maintaining regulatory approval/clearance for Deep Health products

Assist in preparation and review of regulatory submission to authorities.

Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action.

Utilize technical regulatory skills to propose strategies on complex issues.

Ensure compliance with product post marketing requirements.

Review product labeling to ensure compliance with relevant regulatory requirements.

Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees. Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.

Work with the clinical teams to ensure compliance for pre- and post-market clinical studies in support of Deep Health products and product changes.

Ensuring timely submission of adverse events to the appropriate regulatory bodies.

Please Note: This is not an exhaustive list of all duties, responsibilities and requirements of the position described above. Other functions may be assigned, and management retains the right to add or change duties at any time.

Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.

Experience with US FDA Class I and II medical devices. Additional experience with FDA Class III devices and OUS device classification a plus.

Experience interacting with US and OUS Regulatory Authorities, including Q-Submission meetings, and product Deficiency Response meetings, and regulatory inspections.

  • Regulatory Affairs Specialist

    5 days ago

    Navi Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 6,00,000 - ₹ 8,00,000

    Regulatory Affairs SpecialistOur organization is seeking an experienced Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong understanding of US FDA regulations and ICH guidelines.Key Responsibilities:• Develop and implement regulatory strategies for new and existing products• Collaborate with cross-functional teams to...

  • Regulatory Affairs Specialist

    2 weeks ago

    Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 30,00,000

    Job OverviewThe Manager of Regulatory Affairs will be a specialist professional with comprehensive knowledge in the area of regulatory affairs.Main Responsibilities:Develop and manage product registration submissions, progress reports, supplements, amendments, or periodic experience reports as a highly experienced and knowledgeable resource within the...

  • Regulatory Affairs Specialist

    2 weeks ago

    Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 1,04,000 - ₹ 1,30,878

    Job Overview:">Lead Consultant - Regulatory Affairs Specialist. At our company, we are seeking an experienced and skilled professional to support our clients in regulatory affairs. The ideal candidate will have a strong background in chemistry, manufacturing, and controls (CMC) with excellent analytical and problem-solving skills.">The role involves...

  • Regulatory Affairs Specialist

    2 weeks ago

    Mumbai, Maharashtra, India Tek Support Full time

    Job DescriptionJob Title: Regulatory Affairs Specialist Med/Pharma (Female)Location: RemotePosition Overview:We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities,...

  • Regulatory Affairs Specialist

    2 weeks ago

    Mumbai, Maharashtra, India Tek Support Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    Job Title:Regulatory Affairs Specialist Med/Pharma (Female)Location:RemotePosition Overview:We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring...

  • Regulatory Affairs Specialist

    1 week ago

    Mumbai, Maharashtra, India Tek Support Full time

    Job Title: Regulatory Affairs Specialist Med/Pharma (Female) Location: Remote Position Overview: We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring...

  • Regulatory Affairs Specialist

    1 week ago

    Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 25,00,000

    Job Title: Regulatory Affairs SpecialistKey Responsibilities:Develop and oversee systems for regulatory compliance, licensing, and reporting.Establish and implement compliance frameworks aligned with food safety regulations.Provide strategic advice on regulatory matters across domains including Health, Safety, Environment, Food Safety, Pollution Control,...

  • Global Regulatory Affairs Professional

    2 weeks ago

    Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 1,29,99,600 - ₹ 2,09,98,800

    Job Title: Global Regulatory Affairs Specialist">Job Summary: We are seeking an experienced Global Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for managing the regulatory affairs of our products in emerging markets.">Key Responsibilities:">"> Manage the registration process for our products in emerging...

  • Regulatory Affairs Expert

    1 week ago

    Mumbai, Maharashtra, India beBeeSpecialist Full time ₹ 15,24,000 - ₹ 2,01,12,000

    Job Description:We are seeking an experienced Regulatory Affairs Specialist to operate as an individual contributor under limited supervision. The role requires applying subject matter expertise in Regulatory Affairs to ensure compliance and successful product approvals. The ideal candidate will have the capacity to adapt their skills and knowledge to meet...

  • Regulatory Affairs Specialist: CMC Associate

    1 week ago

    Mumbai, Maharashtra, India beBeeCMC Full time ₹ 9,00,000 - ₹ 12,00,000

    Regulatory Affairs Specialist: CMC AssociateWe are seeking a highly skilled Regulatory Affairs Specialist to support US FDA submissions and lifecycle management activities.Main Responsibilities:Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.Maintain...