Magellan is the first cloud-based compliance platform for Medical Devices and IVD products.
The Regulatory Affairs Specialist will play a key role in the development and update of Regulatory Intelligence information. This role will support in defining Regulatory Affairs needs worldwide, focusing more particularly on the critical assessment of key country-specific requirements during all product life cycle stages, and highlighting the differences that may influence or impact companies’ strategy to enter in the market (i.e. pre-market submission requirements, Quality Management System certification acceptance, business/local representative requirements, etc.).
The Regulatory Affairs Specialist will build a solid experience in healthcare products Regulatory Intelligence worldwide.
Responsibilities and Duties
Development and maintenance of Medical Device and IVD Regulatory Intelligence Database contents
- Actively participate in Medical Device and IVD regulatory content development as per specifications and project schedule, acting as internal expert for a set of countries
- Monitor evolution of Medical Devices and IVDs regulatory landscape worldwide. Assess the changes in the Regulatory Affairs requirements and implement changes in the database.
- Ensure Regulatory contents are consistent with currently regulatory practice
Customer and Internal support
- Provide customer and internal support and expertise
- Communicate relevant information to concerned stakeholders
- Work effectively with in country representatives. Participate in research to identify local device Regulatory Affairs experts as required
Knowledge, skills and qualifications
- Fluent in English. Another language (i.e. Spanish, French, Arabic, Chinese or Japanese...) is preferred
- BS degree in Life Sciences or a scientific/technical discipline
- Minimum 1 to 3 years Medical Devices and/or IVDs Regulatory Affairs experience
- Working knowledge on devices regulatory submissions, product approvals and communications with Health Authorities
- Proficiency with Microsoft Office Products such as Word, Excel and Power Point or equivalent software application
- Working knowledge of technology methods, logic and operational capabilities such as Adobe, database and websites, is preferred
- Good problem solver and able to demonstrate good judgment in decision making and setting priorities.
- Demonstrated ability to work collaboratively and within an entrepreneurial environment. Ability to work successfully on multiple tasks under pressure of time and workload.
- Capability to work remotely in an international environment
- Team spirit and good communication skills and proactivity
This is a full-time position located in Vancouver.
Please respond to via indeed platform and include annual salary expectations
Job Types: Full-time, Contract, Permanent
- MD/IVD Regulatory Affairs: 1 year (Preferred)
- other languages (Required)