Job Title

Job Description

Head of Regulatory Affairs, CT/AMI

Your role:

• Leading the Global CT-AMI Regulatory Affairs team from end to end (product inception through to lifecycle management), driving significant innovation, actively providing value-added regulatory affairs input and deliverables for new product introductions and product changes across the globe.
• Leading performance management of the Business Unite Regulatory Affairs team, using metrics and key performance indicators to drive decision-making, meaningful actions, and continuous improvement.
• Leading the development and deployment of innovative Regulatory strategies with the Business Unit Regulatory Affairs team to bring products efficiently and compliantly to the market and maintain them compliantly to support business growth.
• Leading strategic AOP management to optimize revenue and expenditure; leading strategy and execution of functional excellence to improve performance of the regulatory function and bring increased value to the CT-AMI Business Unit.
• Providing interpretation of global regulations through the regulatory council; Providing critical input on regulatory risk assessments to support portfolio selection.
• Managing the relationship and efficient flow of information between Business Unit and regional Regulatory Affairs teams. Building proactive, robust, strategic relationships with external stakeholders (FDA, NBs, CA, MedTech forums, etc.) to influence and shape the external regulatory landscape across the domains relevant to the innovation agenda.
• Leading and enabling cross-functional partnership between Regulatory Affairs and all key stakeholders including R&D, Marketing, Quality, Clinical Affairs, and other functions at all levels within the Business Unit.
• Responsible for the hiring and development of critical talent within the Global Regulatory Affairs Team through creating and sustaining robust career & development plans, ongoing coaching, and feedback, and identifying and addressing gaps in capabilities and competencies.

You're the right fit if:

• You’ve acquired 12+ years (preferred) experience working in Regulatory Affairs within the Medical Device industry. Experience with SaMD, AI and/or digital health is a significant advantage. 10+ years of people management experience with a strong track record in successfully leading a Regulatory Affairs team required.
• Your skills include extensive experience and knowledge of global medical device regulations, requirements, and standards required. You have a proven track record of leading in a matrix organization, leading cross-functional and diverse teams with challenging goals.
• You have a master’s degree (preferred) in a life-science or engineering field or equivalent combination of education and experience.
• 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 experienced in strategic relationships with external stakeholders (e.g., Notified Bodies, FDA, Competent Authorities). You are also experienced with successful preparation and submission of Design Dossiers, 510(k), PMA, Technical/Design Dossiers and international documents or registration of medical devices worldwide.

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 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 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 commitment to diversity and inclusion.

Philips Transparency Details

The pay range for this position in Cleveland, OH is $137,900 to $236,400.

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.

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.