Associate Director, Regulatory Affairs – In Vitro Diagnostics, Digital Health

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in developing regulatory strategies for devices throughout their lifecycle, including development, submissions, and commercialization.

• Organize regulatory pathways, development schedules, and commercialization strategies.

• Facilitate meetings with health authorities focused on In Vitro Diagnostics and Digital Health Technology.

• Articulate regulatory positions during interactions and discussions with agencies.

• Relay essential program updates and regulatory concerns to senior leadership.

• Foster relationships with internal teams and external partners involved in device development.

• Keep abreast of emerging technologies and global regulations that affect diagnostics and digital health.

⛳️ Requirements

• A Bachelor’s degree in a scientific field.

• A minimum of 8 years of experience in the pharmaceutical or medical device industry.

• At least 5 years of experience in regulatory affairs related to Medical Devices/In Vitro Diagnostics.

• Proficiency in U.S. medical device submissions, including pre-submissions, Investigational Device Exemption (IDE), 510(k), and Premarket Approval (PMA).

• Familiarity with international device regulations, including Medical Device Regulation/In Vitro Diagnostic Regulation (MDR/IVDR) and PMDA standards.

• Understanding of regulations pertaining to Companion Diagnostics, In Vitro Diagnostics, and Digital Health Technology.

• Excellent project management capabilities.

• Strong communication skills, both written and verbal.

• Capability to collaborate effectively and influence stakeholders.

🏝️ Benefits

• Annual bonuses or other incentive programs.

• Equity compensation.

• Pension or retirement plans.

• 401(k) company matching.

• Health and wellness initiatives.

• Access to fitness centers.

• Comprehensive medical, dental, vision, life, and disability insurance.

• Paid time off.

• Family support services.

• Reasonable accommodations for applicants with disabilities or chronic health conditions.