Regulatory Affairs Business Specialist

Job Title
Regulatory Affairs Business Specialist

Job Description

Regulatory Affairs Specialist
Establish, maintain, and implement policies and practices related to creating and maintaining an active involvement in the legal and regulatory processes of covered Competent Authorities

Your role:

• Assists in implementing comprehensive regulatory strategies by collaborating with regulatory and cross-functional teams to ensure alignment with company objectives and compliance with relevant regulations for limited scope typically smaller and less complex projects.
• Demonstrates basic understanding of regulatory's role in the Quality System with basic awareness of product lines, disease states, and customers, possessing general knowledge of business developed through education or past experience.
• Collaborates with central and regional Regulatory Affairs teams to support establishment registration and listing, and UDI/Global Trade Identification Number (GTIN) related activities, maintaining processes for regulatory filings/ licenses and developing technical contribution.
• Assists in coordinating and developing conformity assessment strategies and plans essential for supporting regulatory submissions, ensuring alignment with regulatory requirements and standards.
• Supports the coordination and preparation of regulatory submissions for product/solution licensing, ensuring accuracy and completeness to expedite approval processes efficiently, managing files for device updates and related change control processes, supporting the Marketing Teams on Tender related issues.
• Participates in reviewing product/solution labeling and related marketing communications to ensure compliance with regulatory guidelines and standards, primarily at the Business and Field levels.
• Keeps abreast of regulatory procedures and changes, participates in process improvement activities related to internal regulatory processes, as well as evolving Regulatory Agency changes.
  
  

To succeed in this role, you’ll need a customer-first attitude and the following:

• Bachelor's degree in a technical discipline such as Science, Industrial Engineering or a combination of equivalent job experience in related field.
• Minimum of 2 years of experience in the medical device or pharmaceutical industry and technical environment.
• Must have experience with preparation and submission of international documents or registration and marketing of medical device worldwide.
• Excellent working knowledge of medical device regulations (21CFR, ISO 13485), FDA Law, MDR, other global laws and regulations.
• Experience in supporting international registrations.
• Advanced English. Administrative Shift
  
  

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.

This role is an office role/Administrative Shift

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.