Regulatory Affairs Specialist

15 hours 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

    19 hours 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

    2 days 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

    23 hours 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 Specialist

    5 days ago

    Ahmedabad, Gujarat, India beBeeregulatory Full time ₹ 6,54,321 - ₹ 12,34,567

    We are seeking an experienced Regulatory Affairs Specialist to join our dynamic team in Ahmedabad. This full-time position requires a candidate with a strong understanding of regulatory standards and processes.About the RoleManage regulatory submissions and ensure compliance.Facilitate product registrations to support expansion into new markets.Key...

  • Regulatory Affairs Specialist

    4 days 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 days 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...

  • Strategic Regulatory Affairs Manager

    7 days ago

    Ahmedabad, Gujarat, India beBeeRegulatoryAffairs Full time ₹ 22,08,000 - ₹ 30,16,000

    Regulatory Affairs Specialist JobA highly respected medical device firm requires a skilled Regulatory Affairs Specialist to lead the company's regulatory project approvals in various countries. This pivotal role involves strategic development, implementation, and maintenance of global market requirements for our products.About the Role:This is an exceptional...

  • Regulatory Affairs Specialist

    1 week ago

    Ahmedabad, Gujarat, India beBeeRegulatoryAffairs Full time ₹ 5,00,000 - ₹ 10,00,000

    Regulatory Affairs Team Member Job DescriptionAbout the RoleWe are seeking a highly skilled Regulatory Affairs team member to join our project teams. As a key member of the team, you will play a critical role in ensuring compliance with regulatory requirements and contributing to the success of our projects.Key ResponsibilitiesRegulatory Project Plan...

  • Regulatory Affairs Specialist

    6 days ago

    Ahmedabad, Gujarat, India beBeeRiskManagement Full time ₹ 1,04,000 - ₹ 1,30,878

    Job Description:The primary role involves overseeing the scheduling and submission of PSURs and ACOs, ensuring timely completion. This entails coordinating with internal teams to prepare PADER/PSUR/PBRER documents for submission as per their applicable dates.Additionally, the successful candidate will be responsible for managing regulatory affairs requests...

  • Regulatory Affairs Leader

    7 days ago

    Ahmedabad, Gujarat, India beBeeRegulatoryAffairs Full time ₹ 1,75,00,000 - ₹ 2,25,00,000

    Regulatory Affairs LeaderAbout the RoleWe are seeking a skilled Regulatory Affairs professional to lead our team and drive strategic growth in the medical devices industry.Key Responsibilities:Develop and implement a comprehensive regulatory compliance strategy to meet global market requirements for our products.Collaborate with cross-functional teams to...