Regulatory Affairs Manager
In this role, you have the opportunity to
Provide regulatory leadership for OEM (Original Equipment Manufacturer) MRI coils product lines and to build and deliver on competitive regulatory strategies. The Senior Regulatory Affairs Specialist works directly with regulatory agencies to achieve best possible outcomes for effective product market clearances.
You are responsible for
- Supporting the cross functional teams with regulatory guidance during all design control phases of a new product or major changes
- 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
- Responsible for the coordination and preparation of document packages for technical file and design dossiers for CE marking, China (NMPA) CFDA domestic registrations and support worldwide product registrations per in-country regulations
- Provides guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD, MDR, ISO 14155, Canada Medical Device Regulations, etc.
- Involved in developing, modifying and executing company regulatory policies that affect immediate operations
- Recommend and develop strategies and create detailed written regulatory plans
- Identify potential regulatory approvals risks based on changes in regulations, standards, country specific issues or other unique characteristics of the project
- Drive improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System. Review and recommend changes for design process and manufacturing procedures to maintain quality and regulatory compliance
- Responsible for ensuring compliance with regulatory procedures and updating the procedures when new regulatory requirements become effective
- Advise 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
- Review and approve advertising, promotional items and labeling for regulatory compliance
You are a part of
The original equipment manufacturer (OEM) team, working with different business units within the organization to provide regulatory leadership for OEM MRI coils product lines.
To succeed in this role, you should have the following skills and experience
- Bachelor’s degree in a technical/healthcare/business discipline or equivalent
- 10+ years of relevant experience in a medical device company (FDA Class II)
- 10+ years of experience with successful preparation and submission of 510(k)s and a proven track record of success with the FDA
- Strong working knowledge of medical device regulations (21CFR) and FDA law and EUMDD/EUMDR
- Excellent English skills (written and oral)
- Certified regulatory affairs professional would be desirable
- Background in MRI coils or Magnetic Resonance systems is a plus
- Experienced in design control process is a plus
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
In return, we offer you
We welcome you to a challenging, innovative environment with great opportunities for you to explore.
Our benefits are very competitive and designed around your preferences:
- A market conform salary
- 25 Days of leave and the possibility to purchase up to 20 extra days off annually
- A variable bonus based on both Philips results and personal performance
- Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
- Solid company pension scheme and attractive collective health insurance package
- Opportunity to buy Philips shares and products with discount
- Healthy work-life balance
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. 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 on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
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