Director of Regulatory Affairs - RespirTech (Plymouth, MN

Job Title Director of Regulatory Affairs – Respir Tech (Plymouth, MN)

Director of Regulatory Affairs – Respir Tech (Plymouth, MN) The Director of Regulatory Affairs will lead the Philips Respir Tech InCourage Vest Therapy Regulatory Affairs and Quality teams in the development and execution of compliant regulatory strategies and quality team/quality management system (QMS) responsibilities.

• Lead Regulatory Affairs strategy end-to-end execution (product inception through lifecycle management), driving innovation, actively providing value-added regulatory affairs input and deliverables for new 510k product introductions and product changes.
• Use metrics and key performance indicators to drive regulatory and quality decision making, meaningful actions, and continuous improvement.
• Lead the development and execution of regulatory strategies to maintain current products and bring new products to the market in an efficient manner.
• Develop and deploy regulatory resources in an efficient and effective manner.
• Represent regulatory affairs on the management team.
• Be able to articulate compliant regulatory strategy as well as manage operational matters such as Annual Operating Plan (AOP) development.
• Proactively build regulatory capabilities within the business.
• Provide practical interpretation/guidance of regulations, standards and input including risk assessment to support business decision making.
• Build proactive, robust, strategic relationships with external stakeholders (FDA, NBs, CAs, Med Tech forums etc.) to influence and shape the external regulatory landscape across the domains relevant to the business unit innovation agenda.
• Manage, oversee, hire and develop talent within the Regulatory Affairs and Quality teams through creating and sustaining robust career & development plans, ongoing coaching and feedback, and identifying and addressing gaps in capabilities and competencies.
• Ensure compliance with regulatory requirements and internal procedures.
• Empower and enable regulatory affairs and quality team members to foster a culture of collaboration and confident decision-making when working in cross-functional programs and projects.
• Manage/oversee execution of inspection readiness activities, including active inspection support.
• Participate in the coordination and execution of the internal audit program.
• Manage/oversee recall efforts, compliant handling, failure investigation, and adverse event reporting.
• Reporting to the Business Leader, you will lead and enable strong cross-functional partnerships with key stakeholders including R&D, Marketing, Quality, Clinical Affairs and other functions at all levels within the Business Unit.

This role may require travel up to 10%.

• You’ve acquired 10+ years of experience working in Regulatory Affairs and/or Quality/Quality Operations within the FDA regulated Medical Device industry, including 3+ years of experience and a strong track record in successfully leading/managing Regulatory Affairs and/or Quality teams.
• Your skills include:
  Extensive experience/knowledge of global medical device regulations, requirements, and standards (ISO 13485, ISO 14971, 21 CFR 820, etc.)
• A proven track record leading cross-functional/diverse teams in a matrix organization, with challenging goals, with experience working in smaller companies desired.
• Experience in building/fostering strategic relationships with external stakeholders (e.g. Notified Bodies, FDA, Competent Authorities).
• You have a Bachelor’s Degree (required) in Engineering, Life Sciences, Quality, Regulatory or comparable disciplines.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

You’re an entrepreneur at heart who thrives when working with a small team to deliver big results.

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,…