Quality and Regulatory Affairs Senior Manager
3 weeks ago
Quality and Regulatory Affairs Senior Manager
BioTalent is excited to offer an opportunity to become a pivotal member of a prominent healthcare product provider with a significant international footprint across more than 30 nations.
Key Responsibilities
- Serve as the EU Responsible Person concerning MHRA licenses classified as WDA and Home Office Licenses, acting as the primary liaison for the MHRA.
- Supervise the upkeep of the Quality Management System (QMS).
- Strategically plan, oversee, and evaluate regulatory affairs initiatives while ensuring adherence to pertinent guidelines and regulations.
- Manage and uphold ISO certifications along with CE marking compliance.
- Collaborate with external vendors, contractors, or suppliers.
- Organize and execute inspections and audits of both the site and external partners.
- Lead a team of skilled Quality Professionals.
Essential Qualifications and Skills
- A Bachelor's degree or higher in a Science-related field.
- Significant experience in Quality Assurance/Regulatory Affairs within the pharmaceutical or medical device sectors.
- Proven experience as an EU Responsible Person is mandatory.
- Familiarity with QMS aligned with relevant ISO standards: 9001 or 13485.
- Exemplary leadership abilities with experience in team management.
Preferred Skills
- Accredited Auditor Certification is a plus.
- Solid understanding of Good Distribution Practice (GDP).
- Knowledge of risk management and applicable standards (ISO 14791).
We are in the process of shortlisting candidates for this role. For further inquiries, please reach out for a confidential discussion.
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