Job Title

Regulatory Affairs Specialist

Job Description

The Regulatory Affairs Business Specialist 60 is responsible for recommending 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. The role converts Regulatory knowledge into viable options of solutions with moderate scope/complexity, demonstrating basic regulatory affairs knowledge in multiple areas - different submission types, awareness of  geography regulations and pre/post market requirements, possessing solid understanding with regards to sources of regulatory information. The role works under general supervision on larger, moderately complex project/assignments, contributing to complex strategies and making informed decisions after consultation from supervisor or senior members. The role supports internal/external audits and inspections as needed, acting as an informal resource to guide and mentor junior resources in the team, and performs Change Management activities including hosting of meetings to acquire change details for sustaining products, notifying geographical regulatory partners regarding changes for labeling, manufacturing, supplier, design, and software for regulatory compliance.

Your role:

• 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 registrations such as CE Marking 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.
• Creates, reviews, and validates marketing and labeling materials, providing support to projects and other key regulatory initiatives 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.
• Implements safety and compliance requirements for product development projects and OEM/ODM products, communicating and integrating regulatory standards into the I&D organization through memos, training sessions, and deployment strategies.
• Administers the compliance protocol process within PDLM and MLD, overseeing safety certifications and country specific approvals to ensure products meet international regulatory standards.

You're the right fit if:

• Bachelor's / Master’s Degree in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent. 
• Experience with successful preparation and submission of 510(k) or international documents for registration and/or marketing of medical devices worldwide
• Excellent working knowledge of medical device regulations, FDA law, MDR, other global laws and regulations
• Experience in supporting international registrations (FDA) and clinical investigations
• Regulatory Affairs Certification (in the areas of US, EU, CA, and/or global regulatory affairs). 
• Knowledge of the NMPA requirements . (preference)
• Excellent verbal and written communication skills (English)
• Enthusiastic, self-motivated regulatory professional
• Good communicator and team player who is able to work in a flexible and goal oriented environment
• Structured way of working
• Problem solving and time management skills

Your team

You are part of a team of Regulatory Affairs Specialists based in Best (MRI systems), Bangalore (MRI systems software) and Pune (MRI coils). You will report to the Sr. Manager Regulatory Affairs. It’s a multicultural team and they are all enthusiastic people striving for the best regulatory compliancy.

How we work together
We believe that we are better together than apart. For this role, it means working in-person at least 3 days per week.

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 culture of impact with care here.

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