Regulatory affairs Jobs in Colorado Springs, CO

Director, Quality & Regulatory- Mergers & Acquisitions (M&A)

The Director, Quality & Regulatory M&A is an enterprise Q&R leader for M&A activities and primary interface to deal teams, providing end-to-end leadership across the transaction lifecycle, with a focus on complex divestitures, carve-outs, and separations. The role is accountable for defining and executing QMS separation and integration strategies, ensuring continuity of compliance and regulatory obligations from due diligence through post-close. The Director also manages quality and regulatory risks, partnering cross-functionally to deliver compliant, timely outcomes while maintaining QMS integrity and business continuity.

Your Role:

• Lead end-to-end Quality & Regulatory (Q&R) execution across M&A transactions, serving as the primary interface between enterprise deal teams and the broader Q&R organization from diligence through Day 2 transition.
• Define and execute QMS separation and disentanglement strategies for divestitures and carve-outs, including development of Quality Separation Charters, detailed execution plans, and multi-year transition roadmaps.
• Lead complex, cross-functional transaction initiatives involving multiple legal entities, external partners, and regulatory stakeholders, ensuring delivery against time-sensitive milestones and deal objectives.
• Develop and govern Transition Service Level Agreements (TSLAs) and associated operating models, including leadership of transition programs supporting regulatory commitments such as Consent Decree exit where applicable.
• Establish and maintain Master Quality Agreements between RemainCo and NewCo to clearly define ownership of QMS processes, product quality, and regulatory responsibilities.
• Partner with Regulatory Affairs, Legal, and external authorities (e.g., FDA, notified bodies) to define regulatory strategies, manage correspondence, and ensure compliant execution of transaction-related activities.
• Ensure proactive management of quality, compliance, and regulatory risks, including oversight of activities related to external audit findings, FDA 483 observations, consent decree commitments, and internal quality system requirements.
• Lead QMS transition and co-ownership activities during divestitures, including certification strategy, renewal, transfer, and ongoing maintenance of applicable QMS certifications.
• Develop and lead execution of product quality and regulatory transition strategies, including migration of responsibilities, oversight of design changes, and continuity of product lifecycle management.
• Drive Day 1 readiness and Day 2 execution, partnering with cross-functional teams (including Process & System Excellence) to ensure operational continuity and successful separation.
• Provide oversight of product quality performance during transition, including monitoring of complaints, recalls, field actions, and adverse event reporting to ensure compliance and patient safety.
• Partner with manufacturing sites, supply chain, and supplier quality organizations to ensure alignment on QMS processes, procedures, and controls supporting ongoing operations during and after separation.
• Ensure effective execution of QMS governance activities under TSLA frameworks, including internal audits, management reviews, quality data monitoring, and support to global market organizations.
• Support financial and operational planning for transactions, including assessment of stranded costs, resource requirements, and impacts to Annual Operating Plan (AOP).
• Provide governance, reporting, and executive updates to senior leadership and steering committees, including tracking of key risks, milestones, and performance indicators.
• Ensure successful transition and exit of transition services, including full transfer of Q&R responsibilities and retirement of TSLA obligations prior to completion of Day 2.

You're the right fit if:

• You have a minimum of 15+ years' experience in FDA regulated global medical device environments (Class III products/devices preferred) with demonstrated experience/expertise in cross-functional Program leadership/management, focused on Quality/regulatory compliance, change management and M&A within global/matrixed medical device organizations.
• You have extensive leadership experience in various aspects of Quality, such as M&A, design quality, quality systems, post market surveillance and internal / external audit representation for multi-site business in a large multi-national company
• You're experienced in utilizing Quality system metrics/KPI's to drive high performance.
• You have detailed knowledge of global medical device regulations, requirements, and standards, such as FDA, ISO13485, ISO14971, EUMDR for all classifications of medical devices.
• You're very familiar with business process management frameworks including best industry practices related to QMS
• You're a highly collaborative influencer who is an effective communicator and relationship builder.
• You have a minimum of a Bachelor's degree in Quality, Regulatory, Life Science, Engineering or similar technical discipline- required, Master's degree/MBA strongly preferred
• 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 a part. 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-based 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 of 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 Cambridge, MA, Bothell, WA and San Diego, CA is $181,000 to $288,000.
• The pay range for this position in Plymouth, MN and Chicago, IL is $170,000 to $270,000
• The pay range for this position in CO Springs, CO, and Nashville, TN is $162,000 to $258,000

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.

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.

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 Cambridge, MA, Bothell, WA, San Diego, CA, Plymouth, MN, CO Springs, CO or Nashville, TN.
• May travel up to 15%