Senior Manager Regulatory Affairs

2 weeks ago

Ahmedabad, Gujarat, India United HR Solutions Pvt. Ltd. Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Designation: Regulatory Affairs Manager

Industry: Medical Devices (Orthopedic devices preferred)

Experience required: 10 to 15 Years

Location: Sanand, Ahmedabad

Company overview:

A globally‑recognized orthopedic medical device firm founded in 2003, delivering cutting-edge sports‑medicine and extremities implants and instruments across six continents

Driven by innovation, quality and clinical value, the team remains privately held and proudly owned, maintaining a collaborative, family‑style culture.

Duties and Responsibilities:

  • Responsible for strategic development, implementation, maintenance, and overall success of the company's regulatory project approvals in different countries.

  • Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements for our products and ensure alignment with our overall business Strategy.

  • Global coordination for regulatory planning and execution, for the development and market introduction of Company Products

  • Regulatory compliance and medical device registration in Asia, Africa, ANZ, Middle East, Europe and LATAM countries. Management of a team of RA coordinators for different countries.

  • Draft, review, edit, and maintain all departmental policies and procedures, including Post approval changes, regulatory review of order, label and IFU requirements, Language translation needs, Marketing claims etc.

Take charge of your next career move

Apply directly or email your CV to

or

and open doors to valuable opportunities with a trusted recruitment partner.

Contact Person

Ansuya Satish / Anjali Batheja

/

  • Senior Regulatory Affairs Executive

    2 weeks ago

    Ahmedabad, Gujarat, India Medipharma Konnect Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    We are hiring a highly experienced Senior Regulatory Affairs Executive for our pharma company in Ahmedabad. The role involves dossier preparation & submission (CTD/ACTD/eCTD), product registration, regulatory strategy, compliance with WHO-GMP/ICH/global guidelines, and handling ROW, LATAM, SEA, Africa, Pacific market approvals.The candidate will also...

  • Regulatory Affairs Manager

    4 days ago

    Ahmedabad, Gujarat, India Red Envelope Consultants Full time

    Job Title: Senior Regulatory Manager – RoW MarketDepartment: Regulatory AffairsJob Summary:The Senior Regulatory Manager will be responsible for the preparation, review, and submission of high-quality regulatory dossiers and documents for pharmaceutical products intended for Rest of the World (RoW) markets, ensuring compliance with country-specific...

  • Senior Regulatory Affairs Officer

    2 weeks ago

    Ahmedabad, Gujarat, India Lifelancer Full time

    Job Title Senior Regulatory Affairs OfficerJob Location Ahmedabad Gujarat IndiaJob Location Type On-siteJob Contract Type Full-timeJob Seniority Level AssociateSkills Regulatory Affairs Quality Assurance Regulatory Strategy Development Class III Medical Devices Product Registration international legislation accreditation requirements ...

  • Regulatory Affairs Specialist

    1 week ago

    Ahmedabad, Gujarat, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000

    About Regulatory AffairsRegulatory Affairs professionals play a vital role in ensuring the timely and successful submission of high-quality regulatory labeling submissions. They work closely with cross-functional teams, including Compliance, Marketing, R&D, engineering (packaging), manufacturing, and QA/QC.Main Responsibilities:Ensure the on-time filing of...

  • Regulatory Affairs Specialist

    7 days ago

    Ahmedabad, Gujarat, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 28,00,000

    Regulatory Affairs RoleObjectiveWe are seeking a highly skilled Regulatory Affairs professional to join our team. The successful candidate will be responsible for preparing, reviewing and maintaining regulatory documents to ensure compliance with international guidelines and country-specific requirements.Required Skills and...

  • Senior Regulatory Affairs Executive

    2 weeks ago

    Ahmedabad, Gujarat, India Red Envelope Consultants Full time US$ 90,000 - US$ 1,20,000 per year

    Job Title: Senior Regulatory Executive RoW Market ( LATAM Specially)Location: AhmedabadExperience: 5–7 years in Regulatory Affairs (RoW markets)Qualification: B.Pharm / M.Pharm / Life SciencesKey Responsibilities:Prepare & review CTD/eCTD/non-CTD dossiers for new registrations, renewals, and variations.Coordinate with agents/distributors for submissions...

  • Regulatory Affairs Officer

    2 days ago

    Ahmedabad, Gujarat, India CLAPS Industries Private Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Company DescriptionCLAPS Industries Pvt Ltd. is a global pharmaceutical company founded by a team of visionary and successful individuals in the pharmaceuticals field. With a focus on delivering top-quality healthcare products and services worldwide, CLAPS is rapidly growing through product diversification, strategic manufacturing expansions, and strong...

  • Regulatory Affairs Specialist

    4 weeks ago

    Ahmedabad, Gujarat, India Frisch Medical Devices PVT LTD Full time

    Job Title: Regulatory Affairs Junior ManagerLocation: At Ahmedabad Office , Near Thaltej Crossroads Department: RA Reports To: RA Head and Regulatory Department at HO /Director Employment Type: Full TimeOffice hours : 9,30 AM to 6 PMWeek of: Sunday and Saturday Half Day Preferred Gender : M/FExperience: Minimum 2 years Job Summary:We are seeking a...

  • Regulatory Affairs Specialist

    2 weeks ago

    Ahmedabad, Gujarat, India Frisch Medical Devices PVT LTD Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Job Title: Regulatory Affairs Junior Manager Location: At Ahmedabad Office , Near Thaltej Crossroads Department: RA Reports To: RA Head and Regulatory Department at HO /Director Employment Type: Full Time Office hours : 9,30 AM to 6 PM Week of: Sunday and Saturday Half Day Preferred Gender : M/F Experience: Minimum 2 years Job Summary: We are seeking a...

  • Regulatory Affairs Specialist

    2 weeks ago

    Ahmedabad, Gujarat, India Frisch Medical Devices PVT LTD Full time

    Job Title: Regulatory Affairs Junior Manager Location: At Ahmedabad Office , Near Thaltej Crossroads Department: RA Reports To: RA Head and Regulatory Department at HO /Director Employment Type: Full Time Office hours : 9,30 AM to 6 PM Week of: Sunday and Saturday Half Day Preferred Gender : M/F Experience : Minimum 2 years Job Summary: We are...