As a member of the Regulatory Operations team, the Regulatory Operations Specialist provides regulatory support for BG Ultrasound product lines and is responsible to build and deliver on competitive regulatory strategies. The Regulatory Operations Specialist works directly with regulatory agencies to achieve best possible outcomes for effective product market clearances while also being responsible for the coordination and preparation of document packages for regulatory submissions (FDA, Health Canada, EU Competent Authorities, CFDA, ANVISA, etc..) and to recommend strategies for clinical studies and evaluations.
You are responsible for
Being the Regulatory Operations representative for BG Ultrasound and assists with regulatory issues related to such items as labeling, SharePoint management, and international communications with internal and external stakeholders.
Preparing documents required in the Development Life Cycle, and recommends strategies for the most efficient and effective approvals of regulatory applications for the business.
Advising 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.
Planning, generating, and coordinating implementation of global medical device labeling related projects.
Coordinating and preparing document packages for regulatory submissions to global regulatory agencies and/or competent authorities [510(k) Pre-market Notifications, PMAs, Product Reports/Supplements, US Device Listings, GUDID (UDI), Technical Files, Declarations of Conformity, Medical Device Licenses] for all manufacturing sites.
Maintaining existing regulatory filings/licenses, managing updates and related change control processes.
Providing guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X & ISO 14155, Canada Medical Device Regulations, etc.
Providing audit and CAPA support.
Describe (in a short paragraph) reasons why a career with Spectranetics should be a candidates 1st choice
To succeed in this role, you should have the following skills and experience
Bachelor’s degree in a technical / healthcare / business discipline or equivalent.
2+ years of relevant experience in a medical device company (FDA Class I or II equivalent – Class III a plus).
Experience with successful preparation and submission of 510(k), PMA, or international documents or registration and marketing of medical device worldwide.
Working knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations and standards including ISO14971, IEC 60601, ISO14155, and other related particular standards. Excellent English skills (written and oral).
Knowledge of the nature and impact that the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) will have on Manufacturers and Notified Bodies.
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. Learn more by watching this video .
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/philips-recruitment-process.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
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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.