Full-Time Senior Regulatory Affairs Specialist - International

• Support regulatory approval of NGS based IVD medical devices in global markets.
• Manage Submission activities to align with Global regulations.
• Prepare, compile, and publish electronic and hardcopy regulatory submissions consistent with applicable regulatory requirements/guidance.
• Support complex CDx development projects with multiple pharmaceutical partners from early development to Health Authority submission.
• Interact with multifunctional teams, regulatory colleagues and pharmaceutical partners to determine optimal regulatory paths towards development and registration activities.
• Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographies and disciplines as relevant to assigned projects.
• Provide regulatory support on project teams.
• Participate in review of labeling changes.
• Review proposed device changes.

• A minimum of BS degree, open to MS or Ph.D. in a scientific/engineering discipline. Advanced degree preferred.
• A minimum of 4 years of experience in regulatory, development, clinical, quality or program management in the medical device or pharmaceutical industry is required, OR minimum of 3 years of relevant experience at an in-vitro diagnostic (IVD) manufacturer or related industry. Regulatory experience required.
• Strong understanding of global regulatory frameworks, with hands-on experience in LATAM and EU regions strongly preferred.
• CDx or IVD device experience is strongly preferred
• Demonstrated project management and organizational skills
• Excellent writing and verbal communications skills
• Self motivated and proactive work style
• Ability to work in a fast-paced/entrepreneurial team environment

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