
Regulatory Compliance Specialist
24 hours ago
**Job Description**
We are seeking a skilled Regulatory Compliance Specialist to join our team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and industry standards.
**Key Responsibilities:**
- Conduct thorough risk assessments and develop effective mitigation strategies
- Develop and maintain robust compliance programs aligned with regulatory standards
- Collaborate with cross-functional teams to ensure compliance throughout the product lifecycle
**Required Skills and Qualifications:**
- Strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5 regulations
- Hands-on experience with validation and testing methodologies
- Proficiency in quality management systems (QMS) and change control processes
**Benefits:**
- Competitive salary and benefits package
- Opportunities for career growth and professional development
- A dynamic and supportive work environment
**Others:
- Experience working in healthcare, CRO, or life sciences environments
- Familiarity with Agile methodology and risk-based validation
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