Safety & Regulatory Engineer at Philips

Shenyang City, Liaoning, China -

Full Time

Start Date

Immediate

Expiry Date

06 Sep, 26

Salary

0.0

Posted On

08 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Safety Engineering, Regulatory Compliance, EMC Design, Medical Device Registration, Product Testing, Requirements Management, Systems Engineering, Hardware Engineering, Software Design, Validation, Risk Management, NMPA Submission, FDA Submission, CE Marking, ISO 14971, IEC 60601

Industry

Hospitals and Health Care

Description

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. At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success. It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations 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. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. Know Your Rights

Responsibilities

Manage safety and regulatory tasks, including type testing and submission documents for NMPA, CE, and FDA certifications. Lead product reviews, inspections, and marketing clearance activities to ensure compliance with international medical device standards.