Sr. Regulatory Affairs Specialist at Philips

Pune, maharashtra, India -

Full Time

Start Date

Immediate

Expiry Date

01 Feb, 26

Salary

0.0

Posted On

03 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

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

Industry

Hospitals and Health Care

Description

Job Title 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: • 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 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. 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. #LI At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success. It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. Know Your Rights

Responsibilities

The Sr. Regulatory Affairs Specialist implements global regulatory strategies and roadmaps, ensuring alignment with organizational objectives while managing regulatory risks. They collaborate with cross-functional teams to support product compliance and facilitate regulatory submissions for new and existing products.