Principal Regulatory Affairs Specialist

Philips Iberica SAU; Plymouth (MN); On-site; USD 120,000 - 193,000; Full time

Job summary

Philips is seeking a Principal Regulatory Affairs Specialist in Plymouth, MN to lead regulatory strategies for innovative medical devices, focusing on compliance with global regulations. You will oversee submissions, collaborate with cross-functional teams, and ensure the successful launch of new products in a fast-paced environment, making a significant impact on healthcare technologies.

Benefits

Generous PTO

401k with up to 7% match

Education reimbursement

Qualifications

• Minimum 7+ years Regulatory Affairs experience in FDA regulated environments.
• Experience with software-enabled medical devices and 510(k) submissions.
• Strong understanding of FDA regulations and ISO standards.

Responsibilities

• Author FDA 510(k) submissions and EU MDR Technical Documentation.
• Provide regulatory support from concept to commercialization.
• Develop regulatory-related SOPs and maintain compliance.

Skills

Regulatory Affairs

Compliance Management

Strategic Planning

Collaboration

Problem Solving

Education

Bachelor’s Degree in Engineering or Regulatory Affairs

Master’s Degree

RAC certification

Job description

Job Title

Principal Regulatory Affairs Specialist

Job Description

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.

#LI-PH1

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.