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