Director of Regulatory Affairs - RespirTech (Plymouth, MN)

Philips
United States
Workplace: OnsiteFull timeUSD 171,000 - 273,000 annuallyFunction: Quality & Regulatory (Non-Software)Experience: 10+ yearsEducation: bachelorsSkills: ["Leadership","Cross-functional collaboration","Coaching","Strategic thinking","Continuous improvement"]

Lead Philips RespirTech InCourage Vest Therapy Regulatory Affairs and Quality teams to develop and execute compliant regulatory strategies and quality management system (QMS) responsibilities. Own end-to-end regulatory execution from product inception through lifecycle management, drive 510(k) submissions and product changes, manage inspection readiness, internal audits, recall efforts, and adverse event reporting, and strengthen cross-functional partnerships to support innovation and efficient market access.

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Philips
Philips
1 month ago

Director of Regulatory Affairs - RespirTech (Plymouth, MN)

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Last checked: 26 days agoStatus: Live

Job Summary

Lead Philips RespirTech InCourage Vest Therapy Regulatory Affairs and Quality teams to develop and execute compliant regulatory strategies and quality management system (QMS) responsibilities. Own end-to-end regulatory execution from product inception through lifecycle management, drive 510(k) submissions and product changes, manage inspection readiness, internal audits, recall efforts, and adverse event reporting, and strengthen cross-functional partnerships to support innovation and efficient market access.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Director level

Key Responsibilities

  • •Lead regulatory affairs strategy end-to-end from product inception through lifecycle management, including 510(k) introductions and product change regulatory deliverables.
  • •Develop and execute regulatory strategies to maintain current products and efficiently bring new products to market, including representing regulatory affairs on the management team and managing AOP matters.
  • •Build regulatory capabilities and provide practical regulatory interpretation/guidance with risk assessment to support business decisions; build relationships with external stakeholders to influence the regulatory landscape.
  • •Manage, oversee, hire, and develop talent within Regulatory Affairs and Quality teams, ensuring compliance and enabling cross-functional confident decision-making.
  • •Oversee inspection readiness, internal audits, recall efforts, compliant handling, failure investigations, and adverse event reporting; lead cross-functional partnerships with R&D, Marketing, Quality, Clinical Affairs, and others.
Travel: Low travel

Pay and Benefits

Salary: USD 171,000 - 273,000 annually
Perks:Paid Leave401kHsaEquityLearning Budget

Key Requirements

  • •10+ years of experience in Regulatory Affairs and/or Quality/Quality Operations in the FDA-regulated medical device industry, including 3+ years leading/managing regulatory affairs and/or quality teams.
  • •Extensive knowledge of global medical device regulations, requirements, and standards including ISO 13485, ISO 14971, and 21 CFR 820.
  • •Proven track record leading cross-functional/diverse teams in a matrix organization, with experience in smaller companies desired.
  • •Experience building strategic relationships with external stakeholders such as Notified Bodies, FDA, and Competent Authorities.
  • •Bachelor’s degree in Engineering, Life Sciences, Quality, Regulatory, or a comparable discipline (required).
Experience:10+ yearsMedical deviceFDA regulatedQuality management systemMedTech
Education:Bachelor's in Engineering, Life Sciences, Quality, Regulatory or comparable disciplines
Skills:LeadershipCross-functional collaborationCoachingStrategic thinkingContinuous improvement
Tech Stack:ISO 13485ISO 1497121 CFR 820QMS510kAnnual Operating Plan (AOP)

Eligibility

Work Authorization:Authorization required. Sponsorship not provided.

Company Brief

Philips
Global health technology company focusing on diagnostic imaging, patient monitoring, and consumer health products. Philips develops medical devices, healthcare informatics, and solutions to improve patient care and personal well-being.
Industry: HealthTech
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Amsterdam, Netherlands
Founded: 1891
Glassdoor
Glassdoor: 3.8
WebsiteLinkedIn