Regulatory Affairs Manager

Job Title

Job Description

Job title:
Regulatory Affairs Manager

Your role:
 

• Leads the process of staying updated on Greater China regulatory requirements for personal medical devices by implementing monitoring systems ensuring all regulatory updates are accurately communicated and acted upon.
• Ensures organizational compliance with Greater China regulations for product registration and commercialization by managing the entire regulatory submission process, overseeing the review and approval of documentation, maintaining local establishment registrations, and addressing any issues or concerns promptly and effectively.
• Coordinates relationships with regulatory agencies (mainly NMPA, TFDA) by maintaining regular communication, attending industry events, representing the organization in regulatory discussions and negotiations, and ensuring positive and productive interactions that facilitate smooth regulatory approvals.
• Implements global regulatory strategies and roadmaps by leveraging a comprehensive understanding of the competitive market landscape and product marketing strategy to ensure alignment with organizational objectives. Works under general supervision and broad guidelines, consistently exercising independent judgment on matters of significance, ensuring adherence to company policies and regulatory requirements while maintaining high standards of performance and accountability.
• Demonstrates substantial understanding of regulator's role in the Quality System with good awareness of product lines, disease states, and customers, possessing general knowledge of business developed through education or past experience.
• Resolves a wide range of moderate complexity requests in creative ways, leads comprehensive safety risk assessments to identify potential safety incidents and regulatory non-compliance, managing these incidents in Trackwise and ensuring corrective actions are effectively implemented.
• Monitors and handles potential regulatory impacts on product safety, implementing continuous improvement processes within the regulatory framework and engaging with cross-functional teams to proactively manage regulatory risks.
• 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.
• Coordinates and facilitates witness testing to ensure products comply with safety regulations, maintaining direct contact with certification bodies, test houses, and regulatory personnel in local sales organizations.
• Takes ownership of regulatory planning for new product introductions and product changes, assisting in the maintenance of regulatory compliance throughout the product lifecycle.
• Supports the development of the regulatory plan, offering guidance on risk assessment and necessary corrective actions to meet regulatory requirements, including product NMPA/TFDA registrations and clinical evaluations.
• Develops and facilitates regulatory submissions for both new and existing products/solutions, ensuring accuracy and completeness to expedite regulatory approval processes effectively, preparing regulatory justifications to support submission filing decisions.
• Reviews marketing and labeling materials, providing support to advertisement review while ensuring compliance with regulatory guidelines and standards.
• Recommends enhancements in systems and processes to solve problems or improve effectiveness of job area by collaborating with other functions, making periodic or ad-hoc revisions to Regulatory SOPs and templates.

You're the right fit if:

Education Bachelor's / Master's Degree in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent.

Work Experience Minimum 6 years of experience with Bachelor's in areas such as Regulatory Affairs, Quality Compliance in Medical Devices Industry or equivalent.

Preferred Skills (Technical/Functional Skills)

• Regulatory Requirements

• Document Auditing

• Data Management

• Regulatory Reporting

• Product Registrations

• Product Labeling

• Strategy Implementation

• Stakeholder Management

• Regulatory Submission Documentation

• Conformity Assessment

• Regulatory Intelligence

• Regulatory Compliance

• Risk Mitigation Strategies

• Continuous Improvement

• Project Management

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 commitment to diversity and inclusion here.