Regulatory Affairs Advisor at Jobgether – United States

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Regulatory Affairs Advisor in United States.

This role is responsible for driving regulatory strategy and ensuring compliance for complex medical devices and diagnostic products across global markets. You will work closely with cross-functional teams to prepare submissions, evaluate product changes, and maintain regulatory registrations while providing expert guidance on regulatory pathways. This position requires a deep understanding of regional and international regulatory frameworks, with the ability to interpret and apply requirements effectively. You will influence product development, mentor colleagues, and support continuous improvement initiatives. The role provides significant visibility with internal and external stakeholders, allowing you to impact both regulatory outcomes and business strategy. You will thrive in a dynamic, fast-paced environment where technical expertise and proactive problem-solving are essential.

• Develop and execute regulatory strategies for complex product lines, ensuring alignment with regional and global requirements.
• Prepare, review, and submit regulatory documentation, including 510(k), PMA, EU/IVD Technical Documentation, NYS DoH submissions, and other international registrations.
• Provide regulatory guidance on labeling, advertising, product claims, and performance data to internal teams and external stakeholders.
• Evaluate product changes for regulatory impact and maintain accurate documentation of submissions, approvals, and communications with authorities.
• Represent the regulatory affairs function on cross-functional teams, contributing to process improvements, change control initiatives, and strategic projects.
• Mentor and train regulatory staff, supporting professional development and knowledge transfer.
• Support compliance monitoring and post-market surveillance activities to ensure adherence to all regulatory standards.

Requirements:

• Bachelor’s degree in life sciences (biology, microbiology, chemistry, medical technology, regulatory science, etc.) or equivalent; advanced degree preferred.
• RAC certification preferred.
• Minimum of 12 years of direct regulatory experience in medical devices, with IVD/CDx or PMA experience strongly preferred.
• Demonstrated knowledge of U.S. FDA, CAP/CLIA/NYS, EU, or Japan regulatory requirements.
• Minimum 5 years of managerial experience preferred.
• Strong project management, analytical, and problem-solving skills with the ability to navigate complex, fast-changing environments.
• Excellent written and verbal communication skills, including the ability to interact with internal teams, external partners, and regulatory authorities.
• Proven experience in process improvement initiatives and cross-functional collaboration.
• High integrity, proactive mindset, and ability to exercise independent judgment within regulatory frameworks.

Benefits:

• Competitive base salary: $146,100 – $182,600 USD, with total compensation adjusted based on experience and qualifications.
• Comprehensive medical, dental, and vision coverage for employees and eligible dependents.
• Life, disability, and other supplemental insurance plans.
• 401(k) plan with company contribution.
• Paid time off, holidays, and flexible work arrangements.
• Professional development opportunities and mentorship programs.
• Access to employee wellness programs and supportive resources.
• Collaborative, mission-driven culture with opportunities to influence global healthcare outcomes.