You are responsible for
Preparing comprehensive regulatory strategies for complex new devices and post market changes. Clearly communicates strategies to RA management, project teams, and business unit leadership.
Preparing regulatory filings for new products, as well as post market changes. As necessary, reviews complex regulatory issues with RA management.
Providing accurate and consistent regulatory recommendations, decisions, and feedback to product development and manufacturing teams.
Able to identify risks within regulatory strategies and project plan and prepare plans for balancing the project risks to projects teams and RA management.
Professionally negotiate directly with regulatory enforcement entities (e.g. governmental agencies, notified bodies, etc.) on regulatory filings at the reviewer level. All significant issues will be reviewed with the RA management.
Following Quality System procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR, CMDR, MDSAP 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 management with training of more junior specialist 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)
Demonstrated ability to handle multiple tasks/projects and manage priorities accordingly
Demonstrated ability to independently identify and initiate tasks/projects in line with objectives
Demonstrated ability conflict with and motivate teammates on project teams
Regulatory strategies and tactics do not require significant revisions from the RA Management.
Knowledgeable in design and conduct of clinical trials
5+ years of medical device experience with BS degree, and work experience in Regulatory, R&D, Quality, Clinical or Manufacturing
Demonstrated expertise in one regulatory geography and knowledgeable in a second geography
Demonstrated experience in major regulatory filings, e.g. Original PMA, IDE, Design Dossier
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.