Job Description

Job Title Regulatory Affairs Excellence Specialist

Job Title: Regulatory Affairs Excellence Specialist
Job Responsibilities
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.
Executes, manages, and prepares U.S. FDA 510(k) pre-market notification submissions--defining regulatory pathways, compiling technical dossiers, coordinating cross-functional inputs, and driving the process through clearance.
Prepares and coordinates FDA Pre-Submissions (Q-Subs) when strategic feedback is required, drafting meeting requests and briefing packages, leading interactions with the Agency, and ensuring follow-up actions are completed.
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.
Minimum required Education:
Bachelor's / Master's Degree in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent.
Minimum required Experience:
Minimum 8-10 years of experience with Bachelor's in areas such as Regulatory Affairs, Quality Compliance, Product Development in Medical Devices Industry or equivalent
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.

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How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart
Our commitment to inclusion and diversity
At Philips, we provide equal opportunities to all our employees and to all eligible applicants for employment in our company , irrespective of age, color, disability, nationality, race, religion, gender, sexual orientation (LGBTQ +), and all aspects that make individuals unique. Encouraging diversity and fostering inclusion are key to our mission of improving the lives of 2.5 billion people a year by 2030 through meaningful innovation. We have fair, transparent, and clear employee policies which promote diversity and equality, in accordance with currently applicable law. For, we believe that life is better when #youareyou.
Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: There's a certain energy when everyone's in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn't office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.
Why should you join Philips?
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

Skills Required