Are you a seasoned Regulatory Affairs professional looking for an exciting opportunity to make a global impact? Philips, a leading health technology company, is hiring a Regulatory Affairs Specialist for its Ultrasound Regulatory Operations team based in Bangalore. This is a full-time position with the application deadline set for February 28, 2025. Don’t miss this chance to join a company dedicated to improving lives through meaningful innovation.
Job Title: Regulatory Affairs Specialist
Location: Bangalore, India
Job Type: Full Time
Job Requisition ID: 548671
About the Role
As a Regulatory Affairs Specialist at Philips, you will play a pivotal role in shaping the regulatory strategy for Ultrasound products worldwide. You will lead efforts to ensure compliance with global regulatory requirements, drive product registrations, and support innovative strategies for accelerated market clearances. This role offers a unique opportunity to collaborate with cross-functional teams and external stakeholders, making a tangible impact on global healthcare.
Key Responsibilities:
- Develop and deploy innovative regulatory strategies for new product introductions (NPI).
- Lead Health Canada submissions and update Australia Essential Principle Checklists and Declarations of Conformity (DoCs).
- Collaborate with international regulatory teams to ensure compliance with global market requirements.
- Provide MDSAP audit support and ensure adherence to SAP regulatory controls.
- Manage EUDAMED, GUDID, and country-specific UDI submissions.
- Support Philips’ Integrated Landscape initiatives, including BlueHeart SAP MBP, Windchill, and Regulatory Information Management (RIM).
- Create, update, and manage Document Change Orders (DCOs) using Documented Information Management (DIM) tools.
- Build strong partnerships with R&D, Marketing, Quality, Clinical Affairs, and other key stakeholders.
Qualifications and Skills
To excel in this role, you should have:
- 6-8 years of experience in Regulatory Affairs, preferably in the medical devices or healthcare industry.
- Proven expertise in global regulatory submissions, including Health Canada, Australia-TGA, Brazil, Russia, Singapore, and Indonesia.
- Knowledge of Software Regulations (SaMD, Cybersecurity, SaaS) and IEC 62304 standards.
- Experience with RIMsys, Windchill, SAP Regulatory Controls, and EUDAMED/GUDID submissions.
- Familiarity with India Medical Device Regulations is a plus.
- A Bachelor’s degree in a relevant field; a Master’s degree or MBA is preferred.
Why Join Philips?
Philips is a global leader in health technology, committed to improving the lives of 2.5 billion people annually by 2030. By joining our team, you will:
- Work in a hybrid model that balances flexibility and collaboration (3 days in the office, 2 days remote).
- Be part of a diverse and inclusive workplace that values individuality and innovation.
- Contribute to meaningful projects that address global healthcare challenges.
- Enjoy opportunities for career growth and professional development.
Our Commitment to Diversity and Inclusion
At Philips, we believe in creating an inclusive environment where everyone feels valued. We provide equal opportunities to all employees and applicants, regardless of age, color, disability, nationality, race, religion, gender, sexual orientation (LGBTQ+), or any other unique aspect. Our mission is to foster diversity and inclusion, ensuring that every individual can thrive and contribute to our goal of improving lives through innovation.
How to Apply
If you are passionate about regulatory affairs and want to make a difference in global healthcare, this is the role for you! Apply now and be part of a team that is shaping the future of health technology.
Application Deadline: February 28, 2025
Job Requisition ID: 548671
