Regulatory Affairs Job at Masimo | Life Sciences | Apply Now
Masimo is seeking a highly skilled Regulatory Affairs Specialist to join its team in Bengaluru, India. This critical role is designed for a professional with a background in Life Sciences or Engineering who can bridge the gap between local Indian regulations and global corporate standards. As part of this Regulatory Affairs Job, you will be at the forefront of managing high-stakes Class II and Class III medical device filings, ensuring that life-saving monitoring technologies reach the patients who need them through a seamless compliance pathway.
- Job Position: Regulatory Affairs Specialist
- Location: Bengaluru, India
- Job ID:
- Job Category:
About The Company
Masimo is a global medical technology powerhouse that has redefined patient safety through its pioneering noninvasive monitoring solutions. Headquartered in Irvine, California, with a massive strategic hub in Bengaluru, Masimo is best known for its Signal Extraction Technology (SET®), which solved the “impossible” problem of monitoring pulse oximetry during motion and low perfusion. For a professional pursuing a Regulatory Affairs Job, Masimo represents an elite environment where the mission is literal: to improve patient outcomes and reduce the cost of care through advanced hospital automation and connectivity.
Key Responsibilities
In this role, you will lead the execution of local and international regulatory strategies, ensuring data traceability and technical accuracy.
Registration & Filings
- Local Indian Regulatory Mastery: Manage establishment registrations and product listings with Indian health authorities (CDSCO). You must be an expert in the requirements for Class II and Class III medical devices.
- Technical Documentation: Support the APAC team in drafting and compiling technical files, tender requests, and formal responses to audit findings.
- BIS & Import/Export: Oversee the BIS (Bureau of Indian Standards) certification process and ensure compliance with IT equipment import/export rules as they apply to medical devices.
Global Coordination & Quality
- Communication Bridge: Act as the local liaison for the global regulatory headquarters, assessing the impact of local regulation changes on international filings.
- Change Management: Utilize systems like Agile (SMCO) to submit and approve sales market change orders and assess the impact of corporate-driven changes.
- QMS Maintenance: Update and maintain Standard Operating Procedures (SOPs) and Quality System Procedures (SQP) to ensure continuous audit readiness.
Qualifications & Expertise
Masimo is looking for a detail-oriented individual with a “can-do” attitude who thrives in a fast-paced project team environment.
- Education: A Bachelor’s degree is required, preferably in Life Sciences or Engineering. A Graduate degree is highly preferred.
- Work Experience: Minimum of 2 years in a medical device Class II/III environment.
- Technical Skills:
- Deep knowledge of ISO 13485 and Indian Regulatory protocols.
- Proficiency in MS Office (Word, Excel, Access) for maintaining regulatory databases.
- Experience with patient monitor systems or software-based medical devices is a significant advantage.
- Soft Skills: Excellent documentation skills with a focus on document traceability and the ability to manage multiple projects individually or as part of a team.
Applying for the Regulatory Affairs Specialist role at Masimo is a defining move for any professional in a Life Sciences Job. This position provides the unique opportunity to manage high-complexity medical device registrations while collaborating with a global team. If you have the required experience in BIS certifications and Class II/III filings, ensure your application for this Regulatory Affairs Job is submitted promptly to join the Masimo team in Bengaluru.
