Regulatory Intelligence Specialist
This is a pivotal role in regulatory affairs, requiring an expert to stay up-to-date with evolving regulations and ensure seamless compliance.
Duties and Responsibilities
* Regulatory Monitoring: Continuously track and analyze local, national, and international regulatory developments impacting the industry.
* Risk Assessment: Identify potential impacts of regulatory changes on products and operations, and implement mitigation strategies as needed.
* Data Management: Organize and maintain regulatory information for easy access and reference.
* Cross-Functional Collaboration: Collaborate with departments like Clinical, GQRA, R&D, and Operations to ensure regulatory compliance and provide guidance.
Work Experience Requirements: A minimum of 5-8 years of experience in regulated industries is necessary. Ideally, 5+ years of regulatory experience.
Education Requirements: A Bachelor's degree in a scientific discipline is required, while a Master's degree is preferred.
Specialized Skills/Technical Knowledge: Strong understanding of medical device regulations, including US 21 CFR Part 820, Canada's Medical Device Regulations, EU's Medical Device Directive and Regulations, Brazil's Classification and Registration Requirements, Japan's Pharmaceutical and Medical Device Act, and Australia's Therapeutic Goods (Medical Devices) Regulations.
Key Qualifications: Proven ability to identify, plan, and drive continuous improvement, excellent written and verbal communication skills, strong analytical and problem-solving skills, and ability to work effectively across different levels and cultures.
About the Role: As a Regulatory Intelligence Specialist, you will play a critical part in maintaining regulatory compliance and driving business success.