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?
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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.