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Philips Senior Regulatory Affairs Specialist United States, Minnesota 710530107
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Job Description
You will prepare comprehensive regulatory strategies and filings for both new and legacy devices including significant device changes. You will clearly communicate strategies to RA management, core teams, and business unit leadership for device change activity. You will design, build, implement, and sustain world-class regulatory affairs recommendations, decisions, and submissions while employing working knowledge of global regulatory requirements.
Your role:
- Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
- Create comprehensive regulatory strategies.
- Develop and prepare product registration submissions for the US, Canada, EU and support worldwide international submissions as assigned.
- Review and approve advertising, promotional items and labeling for regulatory compliance.
- Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
- Communicate application progress to internal stakeholders.
- Collaborate with worldwide colleagues regarding license renewals and updates.
- Communicate with regulatory agencies as needed.
- Support the site audit for the responsible products, including NB surveillance audit, FDA inspection, MDSAP audit, and all kinds of unannounced audits etc.
- Provide audit, CAPA and post market regulatory support as assigned.
You're the right fit if:
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
- Bachelor’s degree or Master’s degree in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry.
- Minimum 5 years of regulatory approvals and submittal experience (EU MDR, Health Canada, USA (PMA, 510k).
- Must be able to manage multiple tasks and perform with accuracy and a high attention to detail.
- Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.
- Proficient knowledge of domestic and international standards.
- Regulatory Affairs Professionals RAC strongly preferred.
- Understand LEAN concepts, methodologies and deployment.
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 improve the lives of others.
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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 commitment to diversity and inclusion .
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Our newly adopted hybrid work concept fuses flexibilitytranslates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.
Hybrid work flexibility means people can meet thechanging demandsof work and home in the mostbalanced, productive,and healthy way.
Our hybrid working model is defined in 3 ways:
There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
schedules. Flexibility isn’t office
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
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