Principal Regulatory Affairs Specialist

Principal Regulatory Affairs Specialist

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 :

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 companys facilities. Field roles are most effectively done outside of the companys 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 wont 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.

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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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.