Regulatory Compliance Expert

1 day ago

Hyderabad Secunderabad Telangana, India beBeeregulatory Full time ₹ 5,00,000 - ₹ 8,00,000

Job Title: Regulatory Affairs Specialist

About the Role

We are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to achieve business objectives.

Key Responsibilities
  • Prepare and review premarket documents for global registrations;
  • Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations;
  • Represent Regulatory Affairs as a team member of product development projects from Concept through Commercialization;
  • Review pre-clinical and clinical protocols and associated reports for submissions;
  • Develop Regulatory Strategies for new or modified products;
  • Monitor and provide information on regulatory environment changes;
  • Communicate with regulatory agencies and/or notify bodies on administrative and routine matters;
  • Document and maintain communication with health authorities;
  • Prepare internal documents for device modifications;
  • Participate in health agency inspections and notified body audits as necessary;
  • Author and/or review regulatory procedures and update as necessary;
  • Review change control documents and assess regulatory impact;
  • Assist in the development/maintenance of regulatory files, records, and reporting systems;
  • Review promotional material, advertising, and labeling for regulatory compliance;
  • Ensure compliance with regulations for MEIC developed products raw materials and prototypes.
Requirements
  • Bachelor's degree in Medical, Mechanical, Electrical Life Science, or other healthcare-related majors;
  • 4-7 years of experience in a Regulatory Affairs role in the medical device and/or pharmaceutical industry;
  • Good understanding of regulations and policies issued by India, US FDA, and EU, with the ability to interpret international regulatory requirements;
  • Excellent written, organizational, and communication skills;
  • Strong attention to detail and ability to handle multiple tasks;
  • Proficient in English (reading, writing, and speaking).
Nice to Have
  • Excellent communication and interpersonal skills;
  • Self-motivated and positive attitude;
  • Ability to quickly establish credibility with all levels of the customer base.

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