Regulatory Affairs Specialist
Regulatory Affairs Specialist
In this role, you have the opportunity to develop and implement global regulatory strategies and road-maps through deep understanding of the competitive market landscape, regulatory/legislative initiatives and product marketing strategy.
- Performs specific regulatory tasks in support of a regulatory filing with oversight from management or more senior regulatory affairs specialists
- Strong organizational skills and time management skills
- Ability to multitask, support multiple projects, function on a global basis, prioritize, and meet project deadlines
With the supervision from the Regulatory Affairs (RA) Management, a Regulatory Affairs Specialist is responsible for:
- Support more senior RA specialists in the preparation of global regulatory filings for new products, as well as product and manufacturing changes.
- Support more senior specialists in the review of engineering change orders
- Developing regulatory tactics for submissions and registrations.
- Preparing post-market submissions i.e. PMA annual reports, updating technical files, and international registrations.
- Reviews regulatory issues with RA management.
- Developing proficiency in global regulatory requirements.
- Developing working knowledge of US, EU, International, and Quality System regulatory requirements
- Developing an understanding of clinical practice of assigned product areas
- Following Philips/ Spectranetics Quality System procedures to ensure compliance with 21 CFR 820, ISO 13485, MDD, PMDA, CMDR and all other applicable regulations.
- BS degree in a relevant field (BS/MS in engineering or science preferred)
- 2+ years of medical device experience with BS degree, and work experience in Regulatory, R&D, Quality, Clinical or Manufacturing
- 0+ years of medical device experience with MS degree
- 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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