Philips

1 week ago

Sr Regulatory Operation Specialist

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 12 hours agoStatus: Live

Job Summary

Lead global regulatory affairs operations for Software as a Medical Device (SaMD), supporting international product registrations across markets such as the US, EU, and Canada. Own end-to-end submission strategy execution, maintain regulatory information systems and repositories, and track licensing/status. Manage product change notices and labeling updates, ensure compliance with key medical software standards (IEC 62304/62366/60601-1), and deliver dashboards and reports using Power BI/Power Automate.

Location: Bengaluru

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Mid level

Key Responsibilities

•Lead and support international regulatory submissions for SaMD and medical device products across global markets, including new registrations, renewals, and change management.
•Manage regulatory operations and systems by maintaining regulatory data in tools such as RIMSYS and SAP and tracking registration/licensing status across regions.
•Maintain regulatory repositories and support registration activities, including Declaration of Conformity, LTFs, 510(k)s, Technical Documentation, and related submissions.
•Initiate and manage Product Change Notices (PCNs), assess regulatory impact of product/software changes, and coordinate timely submissions/notifications.
•Develop dashboards and reports (Power BI/Power Automate) to provide regulatory metrics, submission timelines, compliance status, and support gap assessments.

Key Requirements

•Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or related field.
•10+ years of experience in Regulatory Affairs within the medical device industry.
•Strong experience with Software as a Medical Device (SaMD) regulatory submissions.
•Proven expertise in global regulatory frameworks (FDA, EU MDR, Health Canada).
•In-depth knowledge of IEC 62304 and IEC 62366 and relevant medical device standards, including experience with regulatory information management systems (e.g., RIMSYS).

Experience:10+ yearsMedical devicesSoftware as a medical device (SaMD)

Education:Bachelor's in Engineering, Biomedical Engineering, Life Sciences (or related field)

Skills:Analytical skillsData managementDocumentationTechnical writingStakeholder management

Certifications:RAPS Regulatory Affairs Certification (RAC)

Tech Stack:RIMSYSSAPPower BIPower AutomateMicrosoft Office 365ExcelUDIGUDIDEUDAMED

Company Brief

Philips

Global health technology company focusing on diagnostic imaging, patient monitoring, and consumer health products. Philips develops medical devices, healthcare informatics, and solutions to improve patient care and personal well-being.

Industry: HealthTech

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Amsterdam, Netherlands

Founded: 1891

Glassdoor: 3.8

Website LinkedIn

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Philips

1 week ago

Sr Regulatory Operation Specialist

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 12 hours agoStatus: Live

Job Summary

Location: Bengaluru

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Mid level

Key Responsibilities

•Lead and support international regulatory submissions for SaMD and medical device products across global markets, including new registrations, renewals, and change management.
•Manage regulatory operations and systems by maintaining regulatory data in tools such as RIMSYS and SAP and tracking registration/licensing status across regions.
•Maintain regulatory repositories and support registration activities, including Declaration of Conformity, LTFs, 510(k)s, Technical Documentation, and related submissions.
•Initiate and manage Product Change Notices (PCNs), assess regulatory impact of product/software changes, and coordinate timely submissions/notifications.
•Develop dashboards and reports (Power BI/Power Automate) to provide regulatory metrics, submission timelines, compliance status, and support gap assessments.

Key Requirements

•Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or related field.
•10+ years of experience in Regulatory Affairs within the medical device industry.
•Strong experience with Software as a Medical Device (SaMD) regulatory submissions.
•Proven expertise in global regulatory frameworks (FDA, EU MDR, Health Canada).
•In-depth knowledge of IEC 62304 and IEC 62366 and relevant medical device standards, including experience with regulatory information management systems (e.g., RIMSYS).

Experience:10+ yearsMedical devicesSoftware as a medical device (SaMD)

Education:Bachelor's in Engineering, Biomedical Engineering, Life Sciences (or related field)

Skills:Analytical skillsData managementDocumentationTechnical writingStakeholder management

Certifications:RAPS Regulatory Affairs Certification (RAC)

Tech Stack:RIMSYSSAPPower BIPower AutomateMicrosoft Office 365ExcelUDIGUDIDEUDAMED

Company Brief

Philips

Industry: HealthTech

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Amsterdam, Netherlands

Founded: 1891

Glassdoor: 3.8

Website LinkedIn