Regulatory Affairs Specialist
- Cambridge, MA
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.
- Demonstrated successful experiences on US FDA 510(k)s, EU MDD/MDR, Canada registrations are a must.
- 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.
- Participate Standard Review Board to contribute the standard change/update for the responsible product portfolio.
- Collaborate with R&D team to coordinate testing required to support regulatory submissions.
- 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
- Ensure standard and process compliance.
- Support the site audit for the responsible products, including NB surveillance audit, FDA inspection, MDSAP audit, and all kinds of unannounced audits etc
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 5 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
- Experience with wireless technology or standalone software is a plus
- 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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