Company Overview

Our client is a global biotechnology innovator transforming the future of healthcare through diagnostic excellence. With more than 2,100 employees and a presence in over 100 countries, the company provides rapid testing and point-of-care medical device solutions that address critical healthcare needs—from infectious disease to pregnancy and drug detection. Operating at the intersection of biotechnology, artificial intelligence, and data science, they are delivering smarter, faster, and more accessible diagnostic tools to improve health outcomes worldwide. As they expand their U.S. regulatory infrastructure, the company is seeking a Senior Regulatory Affairs Manager to play a key role in driving innovation through compliance and regulatory strategy.

Position Overview

This is a unique opportunity to join a fast-paced, global organization on the front lines of healthcare innovation. As the Senior Regulatory Affairs Manager, you will be instrumental in leading regulatory strategy, submissions, and approvals for groundbreaking medical devices. You will work cross-functionally with R&D, quality, and leadership to ensure regulatory compliance while accelerating time-to-market. If you’re an experienced regulatory leader with a strong command of FDA processes and a passion for advancing public health through innovation, this is your chance to make a meaningful impact.

Position Responsibilities

• Prepare, review, and submit 510(k), De Novo, and other regulatory submissions to the FDA.
• Lead the end-to-end regulatory submission process for Class II medical devices, ensuring timely and successful approvals.
• Serve as the regulatory expert during product development, providing strategic guidance to R&D and cross-functional teams.
• Maintain up-to-date knowledge of FDA regulations, ISO 13485, and other relevant global standards; interpret changes and assess business impact.
• Conduct regulatory assessments for product modifications and advise on appropriate submission pathways.
• Act as the primary liaison with FDA and other regulatory bodies, managing communications and regulatory correspondence.
• Support internal and external audits as the regulatory subject matter expert.
• Develop and maintain high-quality documentation to support regulatory submissions, audits, and compliance efforts.

Position Qualifications

Required:

• Master’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field.
• 7–10 years of experience in regulatory affairs within the medical device industry.
• Demonstrated success in preparing and leading 510(k) and De Novo submissions to FDA.
• Direct experience interacting with FDA and responding to agency inquiries.

Preferred:

• Advanced degree (Ph.D., JD, or Regulatory Affairs Certification).
• Familiarity with international regulatory pathways (e.g., CE Marking, IVDR).
• Prior experience working in a high-growth or multi-national environment.

Skills & Competencies:

• In-depth knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, and applicable U.S. and international medical device standards.
• Strong project management and leadership skills with the ability to juggle multiple priorities and deadlines.
• Excellent written and verbal communication, including technical writing and regulatory correspondence.
• Collaborative mindset with a solutions-oriented approach to problem solving.
• Detail-driven with exceptional organizational and documentation skills.

Compensation & Benefits

• Highly competitive compensation package.
• Comprehensive medical, dental, and vision insurance.
• 401(k) plan with generous company contributions.
• Flexible Paid Time Off (PTO) policy.
• Additional substantial benefits.

Call to Action

If you’re ready to lead regulatory innovation at a fast-moving biotech company on the cutting edge of global diagnostics, we’d love to hear from you. Apply now and a member of Talentfoot’s recruitment team will be in touch should your experience align with our client’s priorities.

About Talentfoot Executive Search

Talentfoot Executive Search specializes in future-proofing organizations by securing forward-thinking leaders across sales, marketing, eCommerce, product, data, operations, finance, and technology with a track record of accelerating growth, innovation, and profitability. Since 2010, we’ve partnered with more than 2,500 companies and lead the industry with a 98% client success rate. Learn more at Talentfoot.com.