Sr. Regulatory Affairs Specialist
- Cambridge, MA
Sr. Regulatory Affairs Specialist
In this role, you have the opportunity to
provide timely and valued regulatory guidance (written and / or verbal) for multiple sustaining and new product development teams
You are responsible for
- 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 detailed written regulatory plans that can be used to target domestic and international shipment dates.
- Develop and prepare product registration submissions for the US, Canada, EU and select worldwide locations.
- 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
- Maintain regulatory files and tracking databases as required
- 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
To succeed in this role, you should have the following skills and experience
- Bachelor's degree or equivalent internationally-acquired qualifications preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry
- Minimum 8 years of regulatory approvals and submittal experience (EU MDD, Health Canada, USA, etc.)
- 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
- Experience with FDA 510(k) submissions
- RAPs RAC strongly preferred
- Understand LEAN concepts, methodologies and deployment
- May require 5% travel annually with possibly some international
Why should you join Philips?
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
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