Regulatory Affairs Specialist

Welcome to Philips, a global leader in health technology. We are currently seeking a highly skilled and motivated Regulatory Affairs Specialist to join our team. In this role, you will be responsible for ensuring the compliance of our medical devices with national and international regulations. We are looking for someone with a strong attention to detail, excellent communication skills, and a passion for making a positive impact on people's lives. If you are dedicated to upholding regulatory standards and have a desire to contribute to the advancement of healthcare, we encourage you to apply for this exciting opportunity at Philips.

1. Ensure compliance with national and international regulations: The primary responsibility of this role is to ensure that all medical devices manufactured and distributed by Philips are in compliance with relevant regulations and standards.
2. Stay updated on regulatory changes: As a Regulatory Affairs Specialist, you will be responsible for staying up-to-date on any changes in regulations and standards related to medical devices. This includes monitoring updates from regulatory bodies such as the FDA and EU MDR.
3. Conduct audits and assessments: You will be responsible for conducting internal audits and assessments to ensure that all processes and procedures are in line with regulatory requirements.
4. Prepare and submit regulatory documents: This role will involve preparing and submitting all required regulatory documents, such as product registrations, reports, and applications, to relevant authorities.
5. Communicate with regulatory agencies: The Regulatory Affairs Specialist will serve as the main point of contact for all communication with regulatory agencies. This includes responding to inquiries, providing necessary documentation, and addressing any compliance issues.
6. Collaborate with cross-functional teams: This role will involve working closely with cross-functional teams, including R&D, Quality Assurance, and Marketing, to ensure that all regulatory requirements are met throughout the product development and distribution process.
7. Develop and maintain regulatory processes: You will be responsible for developing and maintaining processes and procedures to ensure ongoing compliance with regulations and standards.
8. Monitor product complaints: As part of ensuring compliance, you will be responsible for monitoring and addressing any product complaints related to regulatory issues.
9. Provide training and guidance: The Regulatory Affairs Specialist may be responsible for providing training and guidance to other team members on regulatory requirements and processes.
10. Continuously improve regulatory compliance: This role will require a proactive approach to continuously improving regulatory compliance within the organization, including identifying and implementing best practices.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Pittsburgh, PA, USA is between $60,000 and $90,000 per year. This can vary depending on the specific company and industry, as well as the level of experience and education of the individual. Higher level positions or those with more experience may earn upwards of $100,000 per year.

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.