Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
You are responsible for
- Preparing comprehensive global regulatory strategies for new devices and manufacturing processes. Clearly communicates strategies to RA management, core teams, and business unit leadership
- Preparing global regulatory filings for new products, as well as product and manufacturing changes. As necessary, reviews complex regulatory issues with RA manager.
- Providing accurate and consistent regulatory recommendations, decisions, and feedback to product development and manufacturing teams.
- Able to professionally negotiate directly with government entities (e.g. FDA, notified bodies, etc.) on regulatory filings at the reviewer level. All significant issues are negotiated with the RA manager.
- Following Spectranetics Quality System procedures to ensure compliance with 21 CFR 820, ISO 13485, MDD, PMDA, CMDR and all other applicable regulations.
- Maintaining proficiency in worldwide regulatory requirements. Develop general strategies on more effective interactions with government agencies and agency personnel.
- Assisting the RA manager with training of Specialist II, Specialist I, and Coordinator level Regulatory Affairs staff.
To succeed in this role, you should have the following skills and experience
- BS degree in a relevant field (BS/MS in engineering or science preferred)
- 5+ years of medical device experience with BS degree, and work experience in Regulatory, R&D, Quality, Clinical or Manufacturing
- Ability to work independently and under general direction only
- Ability to manage conflict with and motivate teammates on project teams
- Sufficient oral and written communication skills
- Successfully submitted or participated in the submission of regulatory filings
- Working knowledge or understanding of FDA, ISO, QSR, and EU regulations for handling complaints, reporting incidents, and implementing corrective and preventive actions Knowledge of PC hardware/software, documentation and archives
Why should you join Philips?
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