Regulatory Specialist

15 hours ago


Hyderabad, Telangana, India Sol-Millennium Medical Group Full time

We are seeking a detail-oriented, experienced, go-getter International Regulatory Specialist with a minimum of 3 years of hands-on experience supporting regulatory submissions and compliance initiatives in the medical device industry. Proven ability to navigate regulatory frameworks with a focus on U.S. FDA and Health Canada requirements. Adept at coordinating cross-functional activities, preparing regulatory files, and supporting product lifecycle activities from development through post-market. Strong emphasis in communication and collaboration skills, as well as ownership and accountability within a global cross-functional team.

Key Responsibilities

Own and support regulatory activities for international. Focus on U.S. FDA and Health Canada.

Contribute to and maintain regulatory documentation including product regulatory files, IFUs, and labeling reviews.

Collaborate with R&D, Quality and Business Unit teams to align regulatory documentation and submission content.

Conduct regulatory impact assessments for design changes.

Qualifications

Bachelor of Science in Biomedical Engineering / Life Sciences / Related Field.

Minimum of 3 years of regulatory experience in medical device industry.

Proven experience contributing to regulatory filings.

Strong understanding of international regulatory body regulations. Emphasis on U.S. FDA and Health Canada.

Ability to interpret and apply regulatory requirements to complex technical issues.

Excellent communication, organization, and problem-solving skills.

Experience in supporting responses to regulatory agencies.

Ability to work independently and collaboratively in a cross-functional team environment.

Preferences

Background in Quality Engineering, ensuring alignment between regulatory strategy and quality system requirements.

Proven experience in contributing to international regulatory submissions.

RAC (Regulatory Affairs Certification) or simliar professional certification

Internal Auditor Training



  • Hyderabad, Telangana, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 20,00,000

    Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team. This individual will be responsible for ensuring that our IT systems comply with regulatory requirements and industry best practices.About the RoleJob Summary: The Regulatory Compliance Specialist will work closely with various stakeholders to...


  • Hyderabad, Telangana, India beBeeCompliance Full time ₹ 18,00,000 - ₹ 20,45,000

    Regulatory Compliance Specialist Job Description   Timely Adherence to Regulatory Requirements.AML Transaction Monitoring and Risk Assessment.Compliance Reviews and Departmental Oversight.Regulatory Body Communications and Liaison.MIS Dashboard Preparation for Senior Management.Key Skills and Qualifications:Strong understanding of regulatory...


  • Hyderabad, Telangana, India beBeeCompliance Full time ₹ 20,00,000 - ₹ 25,00,000

    Job Title: Regulatory Compliance SpecialistThe role of a Regulatory Compliance Specialist is to ensure that our organization's products and services comply with all relevant laws, regulations, and industry standards. This includes maintaining accurate documentation, evaluating components and materials against restricted substance lists, and collaborating...


  • Hyderabad, Telangana, India beBeeRegulatory Full time

    Job Title: Senior Regulatory Affairs SpecialistOverviewKamet Consulting Group is a leading management consulting firm serving the life sciences industry. We are currently seeking an experienced Senior Regulatory Affairs Specialist to join our team.Key ResponsibilitiesMonitor and analyze regulatory changes, trends, and developments in the pharmaceutical and...


  • Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 16,97,000 - ₹ 26,19,000

    Job Title:CMC Regulatory SpecialistJob Summary:The CMC Regulatory Specialist will be responsible for finalizing regulatory strategies for assigned products, providing support to execute tasks independently in accordance with global regulations and guidance procedures.They will serve as the CMC Product Lead, accountable for delivering all regulatory...


  • Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 18,00,000 - ₹ 25,00,000

    Seeking a seasoned professional for a key regulatory role.We are seeking an experienced International Regulatory Specialist with a minimum of 3 years of hands-on experience supporting regulatory submissions and compliance initiatives. The ideal candidate will have a proven ability to navigate complex regulatory frameworks with a focus on U.S. FDA and Health...


  • Hyderabad, Telangana, India beBeeRegulatoryAffairs Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Regulatory Affairs SpecialistDr. Reddy’s Laboratories is seeking a highly skilled Regulatory Affairs Specialist to oversee the preparation and submission of regulatory dossiers, ensuring compliance and timely approvals.Job Description:We are looking for an experienced professional to manage activities pertaining to new application submissions for Europe...


  • Hyderabad, Telangana, India Lifelancer Full time

    Job Title Regulatory Affairs Specialist - II-ETJob Location Hyderabad Telangana IndiaJob Location Type HybridJob Contract Type Full-timeJob Seniority Level AssociateAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose breaking down barriers to...


  • Hyderabad, Telangana, India Lifelancer Full time

    Job Title Sr Regulatory Affairs Specialist - ET-HyderabadJob Location Hyderabad Telangana IndiaJob Location Type HybridJob Contract Type Full-timeJob Seniority Level Mid-Senior levelAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose ...


  • Hyderabad, Telangana, India Lifelancer Full time

    Job Title Senior Regulatory Affairs Specialist - SpineJob Location Hyderabad Telangana IndiaJob Location Type HybridJob Contract Type Full-timeJob Seniority Level Mid-Senior levelAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose breaking...