Regulatory Affairs Specialist Hiring – Frisch Medical Devices

Regulatory Affairs Specialist Jobs for Life Sciences Graduates in Ahmedabad – Frisch Medical Devices

Explore Regulatory Affairs Specialist vacancies in Ahmedabad at Frisch Medical Devices. Requires BSc/MSc in Life Sciences, Biomedical Engineering, or Pharmacy with 2+ years’ experience.

Regulatory Affairs Specialist Job Openings in Ahmedabad: Qualifications, Vacancy Details, and Location

Unlock Your Pharma Career: Join Frisch Medical Devices as a Regulatory Affairs Specialist in Ahmedabad

Are you a qualified life sciences graduate seeking a high-impact role in the pharmaceutical and medical devices sector? Frisch Medical Devices Private Limited, a leader in innovative healthcare solutions, is hiring a Regulatory Affairs Specialist for their Ahmedabad office. This opportunity is ideal for professionals with a background in Life Sciences, Biomedical Engineering, or Pharmacy, offering a chance to work with Class III medical devices and ensure global regulatory compliance.

Why Choose a Regulatory Affairs Career in Pharma?

Regulatory Affairs is a critical function in the pharmaceutical and medical devices industry, ensuring products meet stringent global standards for safety and efficacy. Professionals in this field play a pivotal role in navigating complex regulations, supporting product development, and maintaining compliance throughout the product lifecycle. With the growing focus on global markets and regulatory harmonization, skilled Regulatory Affairs Specialists are in high demand, particularly those with expertise in Class III medical devices.

About Frisch Medical Devices Private Limited

Frisch Medical Devices is renowned for its commitment to quality and innovation in the medical devices sector. Located in Ahmedabad, Gujarat, the company offers a dynamic work environment, opportunities for professional growth, and exposure to international regulatory frameworks.

Vacancy Overview: Regulatory Affairs Specialist

Key Details

• Location: Ahmedabad Office, Near Thaltej Cross Roads, Gujarat, India

• Department: Regulatory Affairs (RA)

• Reports To: RA Head and Regulatory Department at HO / Director

• Employment Type: Full-Time, On-Site

• Office Hours: 9:30 AM to 6:00 PM (Saturday half-day, Sunday off)

• Preferred Gender: Open to all (M/F)

• Experience Required: Minimum 2 years in regulatory affairs, preferably with Class III medical devices

Job Summary

As a Regulatory Affairs Specialist, you will support regulatory compliance activities for Class III medical devices. Your responsibilities will include preparing and submitting regulatory dossiers, maintaining approvals, and collaborating with cross-functional teams to align regulatory strategies with business goals. This role requires a proactive approach, attention to detail, and a deep understanding of global regulatory requirements.

Key Responsibilities

• Prepare, compile, and submit regulatory documents for Class III medical devices (US FDA, EU MDR, India CDSCO, etc.)

• Maintain regulatory approvals through timely renewals, variations, and amendments

• Provide regulatory input during product design and development

• Conduct regulatory impact assessments for design/process changes

• Monitor and interpret evolving global regulations and standards

• Coordinate with external regulatory agencies and notified bodies

• Maintain and update regulatory files and records per SOPs and regulations

• Assist in internal audits and inspections

• Ensure labeling, IFUs, and promotional materials meet regulatory requirements

• Participate in risk management, clinical evaluation, and post-market surveillance

Required Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or related field

• Minimum 2 years of hands-on experience in regulatory affairs, specifically with Class III medical devices

• Knowledge of global medical device regulations (EU MDR, US FDA 21 CFR Part 820, ISO 13485, CDSCO)

• Experience in dossier preparation (510(k), PMA, CE technical files)

• Strong analytical, organizational, and communication skills

• Ability to work independently and in a team

Preferred Qualifications

• Certification in Regulatory Affairs (e.g., RAC)

• Experience interacting with regulatory or notified bodies

• Familiarity with eCTD or electronic submission platforms

Call to Action

Are you ready to advance your career in Regulatory Affairs? Apply now Via Linkedin to join Frisch Medical Devices Private Limited

Quick Reference Table