Regulatory Affairs Specialist
Job TitleRegulatory Affairs Specialist
Regulatory Affairs Specialist, Philips Healthcare, (Highland, Hts., Ohio)
The Regulatory Affairs Specialist provides regulatory leadership for DI product lines and is responsible to build and deliver on competitive regulatory strategies. The Regulatory Affairs Specialist works directly with regulatory agencies to achieve best possible outcomes for effective product market clearances. He /She is 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.
Key Areas of Responsibility:
- Is the Regulatory Affairs representative for DI Programs and assists with regulatory issues related to such items as labeling and marketing ideas, prepares documents required in the Development Life Cycle, and recommends strategies for most efficient and effective approvals of regulatory applications for the business.
- Supports the cross functional teams with regulatory guidance during all design control phases of a new product or major changes
- Is directly responsible for the coordination and preparation of document packages for regulatory submissions to the US, EU and Canada [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.
- Provides 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.
Bachelor’s degree in a technical, healthcare, or business discipline.
- 3-5 years of relevant experience in a medical device company (FDA Class I or II equivalent – Class III a plus).
- 3-5 years of experience with successful preparation and submission of 510(k), PMA, or international documents or registration and marketing of medical device worldwide.
- Strong working knowledge of medical device regulations (21CFR) and FDA law.
- Certified regulatory affairs professional would be desirable.
- Experienced in design control process.
- Experience in supporting international registrations desirable
- Review of design changes for impact to regulatory approvals and licensing.
- Providing information and materials for Certificate to Foreign Governments (CFG), Free Sale Certificates, and other Export Certificates
- Represents the regulatory affairs function and processes in external audits at base site and all manufacturing sites where needed. This includes FDA, CFDA, KFDA, PMDA, Notified Bodies, etc.
- Serves as local regulatory interface between the market and business groups
- Serves as local regulatory interface for the global business RA team
At Philips, we are driven by our mission to improve the lives of 3 billion people per year by 2025, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to our employees who share our passion for improving lives, we are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy and respiratory care. Named one of the Top 50 Happiest Companies in America in 2013, we enable our employees to create a legacy in life through their work and support their development through people-centric learning, total rewards and personalized development planning programs.
Here at Philips WE ARE Working Together for a Better Tomorrow:
Philips’ dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people. Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.
Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what’s next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.
Thanks to our employees, we are at the forefront of the Healthcare industry. Healthcare providers, backed by our many market leading solutions, are able to diagnose confidently, improve care, and increase the quality of life for patients across North America each and every day.
Advance your career in an environment that supports work-life balance, health & well-being and continuous learning. Making a difference begins right here, where you come first.
Find out more info about Philips at www.philips.com/na/careers
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
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.
In case of difficulties with your job application please send an email to [email protected]
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