Safety & Regulatory Engineer

Job Title

Safety & Regulatory Engineer

Job Description

Job Responsibilities:

• Plan, schedule, manage, conduct and support safety and regulatory tasks (e.g., type testing including EMC, Safety, performance..., submission documents for NMPA, CE and FDA) with projects assigned

• Decompose system level safety and regulatory requirement to element level.

• Design for safety and compliance to meet the standards and regulation

• Conduct product reviews and inspections according to standards requirements

• Prepare formal product type testing reports for submission with Third-party agencies including NMPA, CB and NRTL

• Work with different agencies including NMPA, NB and FDA to obtain product certifications

• Leading marketing clearance and product registrations activities internal in R&D (NMPA, FDA, EU)

• Support audits conducted by NMPA, CE, MADSAP, Russia, Korean and Brazil etc

• Product Safety & Regulatory roadmap

Desired Qualifications:

• Master’s degree in Electronics, Electrical, Physics or Biomedical Engineering Computer science & technology and 5+ years engineering experience

• Proficiency with medical device safety and compliance, e.g., design for safety , test methods

• Proven excellence in the process of medical device marketing clearance and product registrations (NMPA, FDA, EU)

• Deep insight in ‘’Design for EMC’’ for the complicated medical device

• Knowledge and experience spanning multiple engineering disciplines (e.g. electrical, electronics, physics and systems engineering) is advantageous.

• Medical diagnostic industry awareness

• Evidence of practical knowledge of standards and regulations pertaining to the medical device industry, both domestic and international. This includes but is not limited to organizations such as FDA, IEC, ISO, NMPA, ACR, AAPM, COCIR, MITA and other directives such as RoHS and WEEE. Examples include: FDA 21CFR820.30, IEC 60601-1, IEC 60601-1-2, IEC60601-1-3, IEC 60601-2-44, IEC 62304, IEC62366-1 and ISO 14971.

• Knowledge and experience spanning multiple engineering disciplines (e.g. electrical, electronics, physics and system engineering) is advantageous.

• Experience of Project and process management

Preferred Skills:
Requirements Management
Systems Engineering
Requirements Analysis
Hardware Engineering
Software Design
Product Testing & Validation
Software Testing & Validation

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.
Indicate if this role is an office/field/onsite 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 the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
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 culture of impact with care here.