Director, Regulatory Affairs

1 week ago

Scottsdale, United States Get It Recruit Hospitality Full time

Title: Director of Regulatory Affairs Location: Scottsdale, Arizona (with flexible remote work options for exceptional candidates)

Reporting to the Chief Operating Officer, the Director of Regulatory Affairs will serve as the strategic leader for regulatory compliance and quality systems across our innovative healthcare company. This role is pivotal in ensuring our cutting-edge diagnostic products meet the highest standards of regulatory excellence in both the US and EU markets.

Responsibilities

Strategic Regulatory Leadership:

Develop and implement regulatory strategies that align with our company’s goals and ensure compliance with evolving regulatory frameworks in the US and EU.

Collaborate closely with cross-functional teams, including R&D, Quality, and Operations, to navigate the complexities of regulatory requirements for our diagnostic products.

Represent the company in interactions with regulatory authorities, including preparing and leading meetings with FDA and European Notified Bodies.

EU and International Markets:

Oversee the development of regulatory strategies for our products in international markets, such as Brazil, Canada, the UK, and Mexico.

Work closely with external consultants to prepare technical documentation for CE marking and maintain compliance with international health regulatory requirements.

US Market:

Lead efforts to prepare for potential regulatory changes in the US, including the transition of our products from laboratory developed tests (LDTs) to Medical Device/In Vitro Diagnostics classification under FDA oversight.

Collaborate with our laboratory, quality, and pathology teams to maintain compliance with CLIA, CAP, and other relevant US regulatory bodies.

Quality Systems and Compliance:

Work closely with the Quality team to maintain and improve our quality systems, ensuring adherence to ISO standards and regulatory requirements.

Provide subject matter expertise and leadership during technical audits by Notified Bodies and other regulatory inspections.

Cross-Functional Collaboration:

Serve as a key liaison between regulatory affairs, R&D, operations, and other departments to ensure seamless integration of regulatory strategies into product development and commercialization plans.

Stay abreast of regulatory changes and industry trends, providing strategic insights and guidance to executive leadership.

Qualifications

Bachelor’s degree in a scientific discipline, with a preference for candidates with advanced degrees or certifications in regulatory affairs or quality management.

At least 10 years of experience in regulatory affairs, with a strong background in medical devices, in vitro diagnostics, or related fields.

Demonstrated experience leading successful regulatory submissions, including 510(k), PMA, and CE marking processes.

Proficiency in interpreting and applying FDA and EU regulations, as well as international standards such as ISO.

Excellent communication and interpersonal skills, with the ability to effectively communicate complex regulatory concepts to diverse audiences.

Strong project management skills, with the ability to manage multiple projects simultaneously and drive them to completion.

A commitment to continuous learning and professional development, with a willingness to obtain relevant certifications and trainings.

This position is based at our Scottsdale, Arizona headquarters, with a flexible work arrangement that allows for a minimum of 3-4 days per week in the office. Exceptional candidates from other locations, including Atlanta and Boston, may be considered for remote work arrangements.

We offer a dynamic work environment with opportunities for professional growth and the chance to make a significant impact in the healthcare industry. If you are a strategic thinker with a passion for regulatory excellence, we encourage you to apply.

Employment Type: Full-Time

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