Philips Compliance Manager, R&D in Rancho Cordova, California

Your contribution

Philips IGT-Devices (Image Guided Therapy) is looking for an experienced technical leader to coordinate compliance activities, including REACH and RoHS compliance, for our intravascular imaging and functional measurement consoles and disposables products.

You will be an accomplished leader who is able to blend deep standards and regulation subject matter expertise and technical knowledge to interface with cross functional leaders and experts.

Can you collaborate with technical experts to assess the impact of changing regulations and maintain compliance through design modifications and/or updated processes?

This role requires experience interfacing with cross functional leadership counterparts within the entire IGT business group.

If you are a self-starter with a track record of consistently delivering high quality results related to compliance in the medical devices environment – this could be the job you have been looking for!

Your Responsibilities

  • Engage with Group Sustainability

  • To keep abreast of regulatory developments within or outside of the company including evolving best practices in chemical substances management.

  • To keep informed on changes in chemical substances requirements and assess the potential impact of these changes on organizational processes.

  • To make risk assessments of presence of new substance restrictions in materials, parts and assemblies designed and sourced by the business. Identify and motivate the need to apply for exemptions.

  • Engage with cross functional leaders

  • To draft, modify, and implement local QMS procedures and operating processes/policies in line with Group level (PQMS) procedures to comply with applicable regulations.

  • To conduct periodic internal reviews or audits to ensure that compliance procedures are followed. Where needed modify policies or operating processes to comply with changes to environmental standards or regulations.

  • Engage with development teams

  • To translate regulatory requirements into actionable product specifications

  • To support new product development programs and ensure regulatory related requirements are met.

  • Provide high level technical leadership in compliance activities:

  • Define and lead yearly screening plan for High risk parts sourced from suppliers

  • Evaluate the efficiency of controls and improve them continuously

  • Review the work of R&D engineers when necessary to identify compliance issues. Where needed provide coaching, advice or training related to policies, procedures or legal requirements

  • Prepare reports regarding compliance operations issues and escalate violations of compliance to senior management as appropriate or required.

  • Verify that IT tooling is in place to adequately provide oversight and monitoring in all required areas.

  • Provide assistance to internal or external auditors in compliance reviews.

  • Provide input on strategic planning and administrative matters.

What you will bring

  • 5-10 years of experience collaborating with R&D teams and implementation of regulatory compliance requirements in the medical device environment

  • Knowledge of REACH and RoHS requirements and application to hardware and disposable products

  • Experience with complex electromechanical systems, disposables, and fabrication processes.

  • Medical device Research and Development experience is a must

  • Medical device regulations experience is a must

  • Capability to assess products to determine applicable standards and compliance requirements

  • Demonstrated process leadership and change management within a dynamic fast-paced environment is highly desired

  • Familiar with design techniques and manufacturability

Your qualifications

  • Bachelor Degree or MS in Electrical Engineering or Mechanical Engineering equivalent

  • Project Management training a strong plus

  • Good mix of strategic and execution capabilities

  • Must have strong interpersonal skills

  • Ability to collect, understand and communicate complex product-related requirements

Location: San Diego, CA

Reports to: Director, Consoles R&D

Our offer

Here at Philips WE ARE Working Together for a Better Tomorrow:

Philips' dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people. Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.

Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what’s next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.

Thanks to our employees, we are at the forefront of the Healthcare industry. Healthcare providers, backed by our many market leading solutions, are able to diagnose confidently, improve care, and increase the quality of life for patients across North America each and every day.

Call to Action:

Advance your career in an environment that supports work-life balance, health & well-being and continuous learning. Making a difference begins right here, where you come first.

Ready to start improving lives by putting your personal skills & passions to work? Apply Today!

Find out more info about Philips at www.philips.com/na/careers

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.