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Director of Regulatory Compliance-Oral Healthcare

Philips
Posted 3 months ago, valid for 18 days
Location

Bothell, WA 98011, US

Salary

$46.88 - $56.25 per hour

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Contract type

Full Time

Paid Time Off

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Sonic Summary

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  • The Director of Regulatory Compliance for Oral Healthcare is responsible for developing and executing global regulatory strategies aligned with business objectives and market analysis.
  • Candidates should have a minimum of 12 years of experience in Regulatory Affairs within FDA-regulated environments, along with at least 6 years in a leadership role.
  • The position requires expertise in global regulatory matters, including overseeing documentation for product registrations and compliance throughout the product lifecycle.
  • The salary range for this role in Bothell, WA is between $172,200 and $275,520, with additional compensation and benefits available.
  • Applicants must reside within commuting distance to Bothell, WA, and US work authorization is required for employment.

Job Title

Director of Regulatory Compliance-Oral Healthcare

Job Description

The Director of Regulatory Compliance is responsible for formulating and executing comprehensive global regulatory strategies and roadmaps, ensuring alignment with Oral Healthcare business objectives and competitive market analysis.

Your role:

  • Develop global regulatory strategies by creating and implementing regulatory roadmaps aligned with market trends, legislation, product marketing objectives and staying current on evolving regulations to advise senior leadership on strategic decisions.
  • Be a regulatory authority liaison, acting as the business unit contact with regulatory bodies, ensuring clear communication and fostering relationships to influence decisions and secure approvals.
  • Lead our regulatory compliance team by providing guidance, managing talent, and driving succession planning and growth while maintaining compliance and achieving organizational goals.
  • Ensure compliance across the product lifecycle by overseeing regulatory planning and execution for new products and changes as well as managing filings and approvals by overseeing preparation and submission of documentation for global registrations to enable timely market access.
  • Drive regulatory excellence and continuous improvement by developing plans, assessing risks, implementing actions, and optimizing regulatory processes for efficiency while maintaining high compliance standards.

You're the right fit if:

  • You’ve acquired a minimum of 12+ years' experience in Regulatory Affairs within FDA regulated Medical Device/Consumer electronics environments.
  • You have a minimum of 6+ years as a functional/strategic leader, including mentoring, training, succession planning, hiring, performance management, technical/professional development of team members.
  • You have demonstrated Global Regulatory Domain knowledge/expertise in overseeing the preparation/submission of regulatory filings/documentation, global product registrations/approvals and leading others in global regulatory matters of diverse product categories - Class I medical device, consumer goods and cosmetics.
  • You’re able to communicate, influence and build relationships with Internal/External Stakeholders, regulatory authorities and industry organizations at all levels.
  • You have a minimum of a Bachelor’s Degree (Required), Master’s degree/MBA desired.
  • 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 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 Bothell, WA 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.
  • Company relocation benefits WILL NOT be provided for this position.  For this position, you must reside in or within commuting distance to Bothell, WA.
  • May require travel up to 10%.

#LI-PH1

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 including Disability/Vets and maintains a drug-free workplace.




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