Regulatory Compliance Engineer

Job Title
Regulatory Compliance Engineer
Job Description
Regulatory Compliance Engineer, Oral Healthcare (Bothell based)
The Regulatory Compliance Engineer is responsible for ensuring all products to be globally released comply with all the relevant safety and regulatory policies and standards by implementing requirements, conditions, and enablers. Within this role, you will be linked to the Personal Health Innovation area of Philips.
Your role:

• Establish relationships with certification bodies worldwide if needed (such as Dekta or UL) and coordinate the approbation, test, and verification process via these certification bodies and test houses concerning Philips Oral Healthcare. Execute safety/Regulatory Compliance activities to ensue that the products comply with all regulatory requirements and Philips' policies.
• Deploy regulatory requirements and memo's in the sites, as applicable to Personal Health business. Participate in and advise cross-functional teams on applicable regulations, requirements, and standards, as applicable to Business and/or to Markets. Implement all relevant regulatory requirements in development projects, products, and verify and validate designs regarding these requirements.
• Review development quality reports and plans to ensure that the information required for submissions and product compliance is adequate. Plan, generate, and coordinate regulatory submissions for product/solution licensing.
• Coordinate conformity assessment strategy/plans required to support regulatory submissions. Review and approve product/solution labeling and product/solution-related marketing communications. Create and ensure execution of the labeling plans for products.
• Collaborate in multi-disciplinary project teams representing the safety and compliance team. Represent Philips Consumer Lifestyle in international regulatory bodies on specific subjects if applicable.

You're the right fit if:

• You've acquired 10+ years (preferred) in Research and Development of new products. Experience working with Certification Bodies (e.g., UL, Dekra). Experience in Global product certifications. Medical Device experience preferred.
• Your skills include knowledge of IEC 60335, IEC 60601, EMC and Radio standards. Knowledge of ROHS, REACH, and global environmental requirements as well as understanding of Biocompatibility requirements (ISO 10993).
• You have a bachelor's degree or higher in a relevant field (Engineering, Electrical, or Mechanical preferred) or equivalent experience and education.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
• You have proven analytic capabilities and product knowledge, a network-oriented mindset and ability to interact with all business functions at all levels, and project management/managerial experience/skills.

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 $108,472 to $200,256, 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 to Bothell.
All United States-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips*. Employees may request a reasonable accommodation. *Montana employees, learn more here.
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Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.