
Regulatory Compliance Expert
4 days ago
Job Summary
">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.
">About Us
">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.
">Responsibilities
">- ">
- 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">
Requirements
">- ">
- 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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