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Join RespirTech's team in Plymouth, MN as a Principal Regulatory Affairs Specialist, where you will develop and execute global regulatory strategies for innovative airway clearance therapy devices, enhancing product development, design changes, and field safety corrections across the U.S., EU, and international markets, while supporting products with integrated and standalone software components.

Your role:

+ Author U.S. FDA 510(k) submissions, Pre-Submissions, EU MDR Technical Documentation, and global regulatory submissions, ensuring robust compliance and strategic alignment. Drive regulatory input for product designs and launches by collaborating closely with development teams to integrate regulatory strategies and requirements.

+ Serve as a Regulatory Subject Matter Expert across multiple product lines, providing strategic advice and comprehensive regulatory support from concept to commercialization. Guide design and development teams through regulatory complexities with thorough insights and hands-on assistance.

+ Develop, author, and maintain regulatory-related Standard Operating Procedures (SOPs), work instructions, and templates to ensure alignment with evolving standards and quality systems. Monitor and interpret global regulatory changes, conducting intelligence activities to preemptively address potential impacts on products and processes.

+ Support internal and external audits with detailed preparation and timely communication of regulatory responses to maintain compliance. Collaborate with R&D, Quality, Clinical, Marketing, Operations, and Post-Market teams to address product investigations, defect assessments, and regulatory strategies for corrections, removals, and CAPAs.

+ Provide regulatory training and guidance to cross-functional partners, fostering a culture of compliance and awareness throughout the organization. Review product labeling, promotional materials, and claims substantiation to ensure global regulatory compliance while identifying and implementing process improvements for increased efficiency and operational excellence.

You're the right fit if:

+ You have a minimum of 7+ years’ Regulatory Affairs experience within FDA regulated Medical Device environments, with a minimum of 2+ years working with software-enabled medical devices (SiMD), Software as a Medical Device (SaMD) and a strong understanding of the software development lifecycle (SDLC).

+ You have proven experience authoring/leading the development of 510(k) submissions, Pre-Submissions, EU MDR Technical Documentation, and global regulatory submissions/registrations.

+ You have expertise in understanding, interpretation, and application of FDA 21 CFR 820 Quality System Regulation, EU MDR Regulation 2017/745, ISO 13485, and other relevant standards and regulations.

+ You have the strong written, oral, and interpersonal skills required to work in a team environment as well as an individual contributor with minimal supervision.

+ You are solution and detail oriented, well organized and self-motivated with the ability to negotiate with regulators.

+ You have demonstrated experience developing regulatory strategies and advising teams through new product development and sustaining engineering changes.

+ You thrive in a collaborative, fast-paced environment and enjoy leading regulatory projects and process improvements.

+ You have a minimum of a Bachelor’s degree in Engineering or Regulatory Affairs or equivalent (Required), Master’s Degree, RAC certification is preferred.

+ You are willing to travel up to 20% based on business needs.

+ You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

+ Learn more about our business.

+ Discover our rich and exciting history.

+ Learn more about our purpose.

+ Learn more about our culture.

Philips Transparency Details

The pay range for this position in Plymouth, MN is $120,488 to $192,780.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Company relocation benefits **will not** be provided for this position. For this position, you must reside in **or** within commuting distance to Plymouth, MN **.**

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It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

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