Regulatory Compliance Expert

4 days ago


Karachi, Sindh, Pakistan beBee Careers Full time

Job Summary

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We are seeking a seasoned Regulatory Affairs & Pharmacovigilance Specialist to join our Regulatory team. As a key member of the team, you will play a crucial role in ensuring that our products meet all legal and safety requirements from development to post-market surveillance.

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About Us

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We develop high-quality medical devices that meet both national and international standards – contributing to better patient care and healthcare delivery. Our mission is to provide innovative solutions while adhering to regulatory compliance.

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Responsibilities

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  • Prepare, compile, and submit regulatory documents for product registration and renewals">
  • Communicate with local regulatory bodies to ensure timely approvals and responses">
  • Monitor and report product safety issues in line with pharmacovigilance requirements">
  • Maintain accurate regulatory records and documentation">
  • Stay updated on relevant regulations and ensure internal compliance">
  • Support regulatory inspections (e.g., audits) and respond to queries effectively">
  • Collaborate with QA, Production, and R&D teams to ensure regulatory alignment">
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Requirements

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  • Education: Pharm-D">
  • Experience: 2–3 years in regulatory affairs and pharmacovigilance, preferably in the medical device or pharmaceutical industry">
  • Familiarity with regulatory procedures, dossier formats, and pharmacovigilance systems">
  • Proficiency in MS Office">
  • Strong written and verbal communication skills">
  • Able to work in a fast-paced environment">
  • Paid time off including vacation, sick, and emergency leaves">
  • Health insurance">
  • Reward and recognition programs">
  • Supportive and flexible work environment">
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