
Senior Regulatory Affairs Engineer
As a Senior Regulatory Affairs Engineer at Philips, you will be responsible for helping to ensure that our company is in compliance with all applicable laws and regulations. You will be a key member of our Regulatory Affairs team, and will work closely with other departments to ensure that our products are compliant with the relevant standards in all markets. To be successful in this role, you must have a Bachelor's Degree in Engineering or a related field, and at least 5 years of relevant experience in the Regulatory Affairs field. You must also have excellent communication and organizational skills and be able to work collaboratively with other departments. You must be detail-oriented and have a grasp of the different regulatory standards applicable to our products. If you have an understanding of the development processes of medical devices, this would be an added advantage.We are looking for someone who is passionate and driven to ensure that our products are compliant and safe for the markets we serve. If you have a genuine interest in Regulatory Affairs and are looking for a challenging and rewarding role, we want to hear from you!
Responsibilities:
- Develop and maintain a comprehensive understanding of applicable laws and regulations governing the safety and efficacy of our products.
- Communicate effectively with other departments to ensure that our products meet all relevant standards.
- Monitor and review new and existing regulations, and advise the Regulatory Affairs team accordingly.
- Develop and implement internal processes to ensure compliance with applicable regulations.
- Develop and maintain a network of contacts within the regulatory affairs field.
- Prepare documents for submission to regulatory authorities.
- Track and review regulatory submissions in order to ensure timely submission and approval.
- Prepare and review marketing materials for compliance with regulatory standards.
- Provide guidance and support to other departments on regulatory matters.
- Monitor industry trends and developments in the regulatory affairs field.
Bachelor's Degree In Engineering
Regulatory Affairs Certification
+ Years Of Experience In Regulatory Affairs
Excellent Communication And Problem-Solving Skills
Ability To Work Independently And In A Team
Ability To Multi-Task
Knowledge And Experience With Eu And Us Regulations
And Experience With Medical Device Regulations
Documentation
Engineering
Quality Assurance
Project Management
Data Analysis
Communication
Negotiation
Auditing
Technical Writing
Compliance
Risk assessment
Analysis
Problem-Solving
Interpersonal
Regulatory
Communication
Conflict Resolution
Leadership
Negotiation
Time management
Interpersonal Skills
Organizational skills
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Regulatory Affairs Engineer in Pittsburgh, PA, USA is $80,000 to $112,500 per year. This range may vary depending on the experience and qualifications of the individual.
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Royal Philips is a health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. The company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care.

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