Head of Regulatory Affairs

Job Title

Head of Regulatory Affairs, S&RC

Job Description

Head of Regulatory Affairs, S&RC

Lead and manage global teams of Regulatory Affairs professionals responsible for all Regulatory activities in support of the Sleep and Respiratory Care Business, which has critical global evidence-generation needs.

Your role:

• Responsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy.
• Participate in and advise cross-functional teams on applicable regulations, requirements, and standards, as applicable to Businesses and not to Markets.
• Responsible for identification and support implementation of site certifications to support approbations
• Responsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy.
• Leads regulatory resources to ensure timely product registrations, regulatory planning for new product introductions and product changes, and assists in maintaining regulatory compliance.
• Leads a high-level team of regulatory directors, managers, and other resources to ensure timely product registrations, regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
• Ensure the consistency and maintenance of existing regulatory filings/ licenses, managing updates and related change control processes (generally at the BIU and field level), and Labeling Plans for products.
• Manage compliance to FDA, EU-MDR regulations and other Regulatory Requirements and as required, guidelines and policies to all products and operations are consistent with those regulations.
• Provides the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, as well as leadership and guidance on global regulatory strategies, such as CE Marking, product registrations, and clinical evaluations.
• Responsible for the safety of consumer products and ensuring root cause analysis of safety incidents and product non-compliance with proper follow-up of product improvements.
• Interacts internally and externally with executive-level management, requiring negotiation of extremely critical matters. Influences policymaking.
• Regularly interacts with executives or major customers. Interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior-level leaders regarding matters of significance to the organization.
• Directs and controls the activities of one or more functional areas, divisions, product groups or service areas through directors who have overall responsibility for the successful operation of those assigned areas.
• Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people.

You're the right fit if:

• Bachelor’s degree, preferably in a life-scientific field, and a Regulatory Affairs Certification
• Strong proven track record of leading an organization through consent decree
• A minimum of 15 years of experience working in Regulatory Affairs within a medical device industry. Experience with SaMD, AI and/or digital health is a significant advantage
• Extensive knowledge and authoring of FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), , Technical Documentation)
• A strong background in Design Controls, sleep and respiratory care devices, SaMD, SiMD, AI and/or digital health
• Extensive knowledge of MDD, MDR, MedDev’s, FDA QSR’s, ISO 13485 & 18562, and other applicable major/regional worldwide regulations.
• Working knowledge in regulations concerning device labeling as well as advertising and promotion
• Shown leadership in formulating and implementing global strategies to ensure compliance with worldwide regulations to improve product market access.
• A passion for continuous improvement with associated change management, particularly around transformation, integration and organizational design
• 10+ years of people management – with a strong track record in successfully leading a Regulatory Affairs team bringing products to market on time.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

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.
• Read more about our employee benefits.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

Philips Transparency Details

The pay range for this position is $175,000 to $323,000, annually. The actual base pay offered may vary 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 of one of the listed locations.

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/Disabled/Veteran and maintains a drug-free workplace.