Consultant.e at Colombus Consulting supporting clients from strategic reflection to operational implementation. Involved in project design, client development, and innovative workshop facilitation in various sectors.
About the role
- Senior Consultant RA IVD responsible for regulatory consulting and strategic advisory in IVDs. Working globally with clients to navigate regulatory compliance and strategies within the medical devices industry.
Responsibilities
- Provide specialist regulatory consulting services directly to customers in the IVD sector
- Support clients in defining their regional and global regulatory strategies, submission pathways and lifecycle planning
- Anticipate regulatory challenges across the product lifecycle and assess their regulatory, clinical performance and compliance impact
- Monitor regulatory developments and translate changes into practical advice for clients and internal stakeholders
- Deliver client training sessions, workshops and presentations on regulatory and clinical topics
- Act autonomously in complex decision-making, supporting and defending regulatory positions while escalating as appropriate
- Own, design, author and review regulatory and scientific documentation for IVDs
Requirements
- Master’s degree or PhD in sciences, biomedical, medical or technological fields, or equivalent
- Minimum 8 years relevant experience in regulatory affairs within the IVD, MD or biotech industry
- Proven experience with EU IVDR/MDR and FDA regulatory frameworks
- Minimum 3 years experience in medical and/or regulatory writing
- Minimum 2 years experience conducting systematic literature reviews
- Excellent written and verbal communication skills
- Strong stakeholder and expectation management skills
- Excellent organizational skills and an analytical mindset
- Enjoy working in an international environment
Benefits
- Attractive and competitive salary package tailored to individual needs
- Job security
- Continuous journey of learning and development
- Joyful community for personal growth
- Meaningful connections and celebrations of achievements
Job title
Job type
Experience level
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Not specified
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