Sr. Regulatory Affairs Specialist

Job Description

Job Title : Sr. Regulatory Affairs 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.

• 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 a software, technical, or biomedical discipline

Minimum required Experience:

• Minimum of 10-12 years of experience in medical device regulated environment - Mandatory

• 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

• 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

Preferred Experience:
Knowledge of the NMPA requirements. (preference)
Experience in supporting international registrations (OUS and Outside EU) and clinical investigations
Preferred Certification:
RAPS RAC certification

Preferred Skills:
u2022 Regulatory Requirements
u2022 Document Auditing
u2022 Data Management
u2022 Regulatory Reporting
u2022 Product Registrations
u2022 Product Labeling
u2022 Strategy Implementation
u2022 Stakeholder Management
u2022 Regulatory Submission Documentation
u2022 Conformity Assessment
u2022 Regulatory Intelligence
u2022 Regulatory Compliance
u2022 Risk Mitigation Strategies
u2022 Continuous Improvement
u2022 Project Management

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 companyu00A0, 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.u00A0For, we believe that life is better when #youareyou.

Our hybrid working model is defined in 3 ways:
There's a certain energy when everyoneu2019s in the same room that can heighten idea generation and creative friction needed for problem-solving.
Choosing where, when and how to work can vary according to task and team schedules. Flexibility isnu2019t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
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. Itu2019s 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.

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