Experience Inc. Jobs

Job title:

• Senior Regulatory Affairs Specialist

Job Description:

• The Senior Regulatory Specialist will develop and execute the regulatory strategy for new product development, design changes and field safety corrections for US, EU and RoW.

• Collaborate with the cross functional team (including R&D, design quality, marketing, supply chain etc.) to create submission contents.

• Lead 510(k) submission, preparation of EU MDR Technical Documentation, Health Canada license applications and other global registrations and work with global regulators/competent authorities throughout review and approval process.

• Supports activities required to maintain regulatory compliance as new or revised versions of standards, guidance documents are published.

• Monitor global regulatory landscapes and supports implementation of regulation changes and executes quality plans to minimize business impact.

• Provides Regulatory assessment of product changes for launch and sustaining activities.

• Review labelling, marketing materials, and claims substantiation evidence to maintain compliance with global requirements.

• Identify areas for improvement for efficiency and compliance in internal processes, work instructions, and forms and apply technical expertise to process improvement efforts.

• May lead or participate in process improvement teams to affect changes at a local or cross business unit level.

Job Requirements/Qualifications:

• Minimum of 10+yrs years of experience in the medical device industry with regulatory submission experience. 510(k) submission experience preferred.

• Minimum of a bachelor’s degree in engineering or a related scientific field. Degree within Regulatory Affairs and/or Regulatory Affairs Certification is preferred.

• Proficiency in understanding, interpretation, and the application of FDA 21 CFR 820 Quality System Regulations, EU MDR Regulation 2017/745, ISO 13485, and other relevant standards and regulations.

• Prior experience supporting/leading regulatory submissions such as 510k, EU MDR Technical Documentation and global registrations

• Strong written, oral, and interpersonal communication skills to be able to work in a team environment.

• Solution and detail oriented, well organized and self-motivated.

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 commitment to diversity and inclusion here.