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 seeking a proactive and detail-oriented Regulatory Affairs Executive to support the regulatory compliance activities for Class III medical devices . The ideal candidate will have a strong understanding of global medical device regulations and experience in preparing and submitting regulatory dossiers. You will collaborate with cross-functional teams to ensure regulatory strategies align with company goals and support product lifecycle management.

Key Responsibilities:

  • Prepare, compile, and submit regulatory documents for Class III medical devices in accordance with global regulatory requirements (e.g., US FDA, EU MDR, India CDSCO, etc.).
  • Maintain regulatory approvals by preparing timely renewal applications, variations, and amendments.
  • Support product development teams with regulatory input during the design and development phases.
  • Conduct regulatory impact assessments for design or process changes.
  • Monitor and interpret evolving global regulations and standards applicable to Class III medical devices.
  • Coordinate with external regulatory agencies and notified bodies for regulatory submissions and audits.
  • Maintain and update regulatory files and records in compliance with company SOPs and applicable regulations.
  • Assist in internal audits and inspections, including document preparation and response coordination.
  • Ensure labelling, IFUs, and promotional materials comply with applicable regulatory requirements.
  • Participate in risk management, clinical evaluation, and post-market surveillance activities.

Qualifications:

  • Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field.
  • Minimum 2 years of hands-on experience in regulatory affairs, specifically with Class III medical devices .
  • Knowledge of medical device regulations such as EU MDR , US FDA 21 CFR Part 820 , ISO 13485 , and CDSCO requirements.
  • Experience in dossier preparation (e.g., 510(k), PMA, CE technical files).
  • Strong analytical, organizational, and communication skills.
  • Attention to detail and ability to work independently as well as in a team environment.

Preferred Qualifications:

  • Certification in Regulatory Affairs (e.g., RAC) is a plus.
  • Experience interacting with regulatory bodies or notified bodies.
  • Familiarity with eCTD or electronic submission platforms.

  • Regulatory Affairs Specialist

    1 week ago

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

    Job Title: Regulatory Affairs Specialist - PharmacovigilanceAbout the RoleThis is an exciting opportunity to join our team as a Regulatory Affairs Specialist - Pharmacovigilance, where you will be responsible for ensuring compliance with regulatory requirements and coordinating submissions to relevant authorities.Key ResponsibilitiesPSUR and ACO Scheduling:...

  • Regulatory Affairs Specialist

    2 weeks 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

    2 weeks ago

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

    Job Title:">Regulatory Affairs Specialist', 'Job Description:">Aggregate Safety Reports (PSUR, PBRER, and PADER) related activities.Coordinate with Global Teams and Reg Teams to ensure submissions as per applicable dates.Key Responsibilities:">PSUR/PBRER/PADER scheduling and submission.Review and preparation of PADER/PSUR/PBRER for timely...

  • regulatory affairs

    2 weeks ago

    Ahmedabad, Gujarat, India Sunrise Remedies Full time ₹ 15,00,000 - ₹ 28,00,000 per year

    Sunrise Remedies Job Opening for Regulatory Affairs (RA) officer.Experience: 1 YearIndustries: Pharmaceutical CompanyEducation: B.Sc. | M.Sc | B.Pharm | M.PharmJob Location: Santej Ahmedabad.Facilities Provided:– Transportation Facility Available (As Per Circumference Of Sunrise Remedies)*– Mediclaim and Food Facility provide By Company.*Key...

  • Regulatory Affairs Specialist

    1 week 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...

  • Regulatory Affairs Specialist

    1 week ago

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

    Regulatory Document Specialist Role OverviewJob DescriptionPrepare and manage regulatory documents, such as DMF/ASMF/CEP dossiers, in compliance with ICH M4 CTD/eCTD guidelines. This involves reviewing and revising documentation to ensure accuracy and adherence to regulatory requirements.Key ResponsibilitiesPrepare responses to queries from regulatory...

  • Regulatory Affairs Specialist

    2 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...

  • Senior Regulatory Affairs Expert

    1 week ago

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

    Regulatory Affairs SpecialistWe are seeking a seasoned Regulatory Affairs Specialist to join our team. As a key member of the regulatory department, you will be responsible for ensuring compliance with regulatory requirements and facilitating smooth market access.About This RoleThis role is ideal for an experienced professional with 10-15 years in Regulatory...

  • Regulatory Affairs Officer

    5 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 Executive

    2 weeks ago

    Ahmedabad, Gujarat, India Prompt Career Consultants Full time ₹ 15,00,000 - ₹ 28,00,000 per year

    Prepare, submit regulatory dossiers for new product registrationsCoordinate and manage the submission of regulatory documents Facilitate communication with health authorities, responding to queries Required Candidate profileM. Pharm (Female Candidate Preferred)1 year of experience in Regulatory Affairs in Pharmaceutical Formulations unit desired.Excellent...