Norm Compliance Officer

Job Title

Norm Compliance Officer

Job Description

Norm Compliance Officer

The purpose of this position is to handle end-to-end Norm Compliance activities for Diagnostic X-ray systems as part of the Research and Development team, with all relevant mandatory international and national regulations.

Your role:

• Defining all applicable global product safety certification, product safety, EMC and environmental (if applicable) standards like IEC, EN, and ISO standards required to comply with all applicable international regulations.
• Define and review product requirements related to guidance, codes and standards to assure norm compliance and decomposition of standard requirements to the individual system or sub-systems.
• Preparation of norm compliance test plan that include applicable relevant clauses from standards (standards mainly include IEC60601-1, IEC60601-1-2, IEC60601-1-3, IEC60601-2-54, ISO 10993 etc.).
• Support in risk assessment related to product safety for achieving mitigation.
• Support usability and software teams to deliver documentation required for certification.
• Support design and procurement team to ensure third party component level compliance.
• Execute testing (witnessing, reporting and approval) of all specified product safety requirements.
• Arrangements of DXR product and required documents to test/certification agencies (like TUV/CSA/Any other lab) as part of submission and completion of certification activities.
• Support in preparing technical file deliverables (like GSPR and Compliance Data Record) in support to MDD, MDR, RED, REACH, RoHS regulations.
• Achieve certification of DXR products with all relevant global standards and regulations.
• Ensure timely delivery of all approbation activities / documentation adhering to Philips processes.
• Support the Regulatory team to achieve all regulatory approvals.
• Support all audits (FDA, Notified Body, INMETRO, etc).
• Review standard updates and provide standards gap assessment / technical support to the Regulatory team.
• Provide Training and guide all cross-functional teams on regulatory standards, update and execution.
• Maintain DXR compliance lab and its qualifications with CSA & Intertek as per ISO17025.
• Identification of approbation consequences due to change requests.
• Support factory inspections by certification agencies and address all audit observations in a timely manner (if applicable).
• Keep abreast of future upcoming regulatory & standards by interacting with notified body and standard organizations.

You're the right fit if:

• BE, BTech, ME, MTech degree (preferably in Biomedical/ Electrical/ Electronics/ Instrumentation).
• Minimum 10 to 15 years’ experience in product safety.
• Understanding of global mandatory / voluntary regulations like CE Marking, FDA, Health Canada, UL, CSA, INMETRO.
• Understanding of relevant standards (General Safety, EMC, Radiation Safety, Risk Management, Environmental, Sustainability, ISO17025, etc.).
• Knows how to participate in Design Reviews from norm compliance perspective.
• Knowledge of regulatory submissions.
• Knowledge of X-ray systems will be an added advantage.
• Prior experience in product design will be preferrable.
• Excellent Communication skills.
• Understanding and implementation of good document practice (GDP).
• Strong hold on Compliance standards.
• Knowledge of Product safety and regulatory.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.

Onsite roles require full-time presence in the company’s facilities.

Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This role is an office-based role.

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.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.

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