Job Title

Job Description

Director of Regulatory Affairs Operations, Ultrasound

The Director of Regulatory Affairs Operations for the Ultrasound business will be responsible for leading a global Regulatory Affairs team for end-to-end regulatory affairs input and deliverables for regulatory strategy development of new product introductions, maintaining clearances, and related integrated supply chain and service activities.

Your role:

• Through end-to-end regulatory processes, ensure safe and effective products/solutions are brought to market on-time, and sustained throughout the life cycle via, compliant, innovative regulatory strategies including Service and Integrated Supply Chain projects.
• Provide critical input on regulatory risk assessments to support portfolio selection.
• Build proactive, strategic relationships with external stakeholders (Notified Bodies, U.S. FDA, Competent Authorities, global regulations) to ensure that requirements are known early during strategy development, which enables fast market access with the current portfolio in connection with future innovations.
• Represent the regulatory affairs function at the Ultrasound Leadership Team level.
• Lead and enable strong cross-functional partnership between Regulatory Affairs, and Service and Integrated Supply Chain for all levels within the business, and the local Regulatory Affairs teams in the Philips market organization.
• Responsible for the hiring and development of critical talent within the global regulatory affairs team through creating and sustaining robust development plans, ongoing coaching and feedback, and identifying and addressing capabilities gaps.

You're the right fit if:

• You’ve acquired 10+ years of experience in Regulatory Affairs functions, with a focus in regulatory operations, in the medical device industry (preferred). People leadership experience is preferred. Global experience is required (India, China, EU, US, etc.).
• Your skills include a strong understanding of medical device regulatory requirements and standards at a global scale, knowledge and understanding of manufacturing operations transfer, labeling requirements in various markets, and a strong understanding of the complexity of both the integrated supply chain and services aspects of regulatory affairs. The ideal candidate will have a strong understanding of the refurbishment business within a medical device company.
• You have a bachelor’s degree or higher or an equivalent combination of education and experience. RAC preferred.
• 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 excellent communicator with an ability to drive strategic change cross-functionally. Travel up to 15% (according to business needs).

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 culture.

Philips Transparency Details

The pay range for this position in Plymouth, MN is $161,438 to $258,300

The pay range for this position in Bothell, WA or Cambridge, MA is $172,200 to $275,520.

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.

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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.