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63 Philips Jobs
Norm Compliance Officer
Philips
posted 5hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
In this role, you have the opportunity to support the Norm Compliance activity for Diagnostic X-ray (Radiography, Fluoro & Mammography) with all relevant mandatory international and national regulations including MDD & MDR and Philips Healthcare processes.
You are responsible for
- Own norm compliance portfolio for DXR products and execute end-to-end activities by regulations.
- Work on the project deliverables related to Norm Compliance release evidence - Generate Technical File for MDD & MRDR certification.
- Identification of relevant clauses from standards for (sub)system, Standards mainly includes IEC60601-1, IEC60601-1-2, IEC60601-1-3 etc.
- Definition of product requirements to assure norm-compliance.
- Decomposition towards the individual (sub)system elements.
- Secure the implementation and verification of all specified legal requirements.
- Support concerning technical realization/engineering of norm compliance of the (sub) system.
- Support the verification (testing, witnessing reporting, and approval) of all specified legal requirements.
- Be the intermediary between development and certifying/regulatory agencies ( UL/CSA/FDA/BSI etc).
- Test lab interaction experience.
- Support arrangements for and completion of submission to certifying agencies.
- Review standard updates and deploy revised standards.
- Identification of approbation consequences due to change requests. (Notified Body Audits)
- Train and inculcate design and cross-functional teams on regulatory standards, updates, and execution.
- Contributing to Technology Roadmaps
- Build a norm compliance team and coach them on various activities with the portfolio
You are a part of Diagnostic X-Ray R&D team. Philips HIC, Pune is playing a key role in Philips global strategy for DXR. With Philips HIC, the foundation was laid to touch billions of lives and reiterate Philips commitment towards Indian and growth healthcare markets.
To succeed in this role, you should have the following skills and experience.
- Degree in bio-medical engineering having IQ specialization with ~12+ years of experience with minimum of 5 years of experience in the X-ray system/subsystem design & development (or at least two end-to-end X-ray product development)
- In-depth understanding of system-wide IQ, combining IQ-related theory (e.g. x-ray physics, image processing, visual perception, etc.) with an understanding of relevant products and the application by the end-user.
- Knowledge of relevant regulations (UL, CSA, IEC, ISO, MDD, CE, etc.) and relevant standards (General Safety, EMC, Radiation Safety, Risk Management, Environmental, Sustainability, etc.).
- Knowledge of project organization, PCP, and ISO 13485.
- Knowledge of IEC 60601 standards, risk management, verification, and validation of medical devices
- Knowhow of design control processes for medical device design
- Working knowledge of cabling design, design for EMI/EMC, Design for reliability
- Good team player and ability to work independently & act proactively.
- Analytical, creative, and abstract thinker.
- Ability to communicate (both written and verbal) on different levels.
- Is capable of introducing efficiency improvements on the project level (change management).
- System thinking mindset and domain expertise in the related area
- Fast learner and interested to learn new technologies/business/systems
- Be structured and self-organized
- Excellent communication skills
- Team player, leadership skills, and drive for results
- Mindset to simplify and reach solutions with speed
- Intercultural sensitivity
- Self-motivation
Employment Type: Full Time, Permanent
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What people at Philips are saying
Compliance Officer salary at Philips
reported by
4
employees
with 13-18
years exp.
₹25
L/yr - ₹60
L/yr
413%
more
than the average Compliance Officer Salary in India
View more details
What Philips employees are saying about work life
based on 1.5k employees
Flexible timing
Monday to Friday
No travel
Day Shift
Philips Benefits
View more benefits
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Philips Pune Office Location
Pune Office
Philips Medical System, No.6, 2nd Floor, Dinkar Smruti, Shivajinagar, Bhamburda
Pune
Maharashtra 411005
Maharashtra 411005
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