Sr. Regulatory Affairs Manager
In this role, you have the opportunity to
- Actively contribute in the development and implementation of regulatory strategies for product development and approval (New Product Introduction). You are responsible for specific regulatory documents preparation, review and submission, and assist with compliance issues. You provide regulatory support to other departments, project teams, and committees in managing the development of medical devices and connected products (e.g. vital signs monitoring) for Mother & Child Care business.
You are responsible for
- Manage the day-to-day regulatory affairs activities for specific projects and related domestic and international applications including prepare, coordinate and review multiple submissions and projects effectively. Ensure consistency, completeness and adherence to standards for all regulatory submissions.
- Participate in the study management & regulatory submission teams
- Execute, with appropriate guidance and supervision, product development and regulatory strategies regarding submissions and compliance issues
- Regulatory assessment of product claims
- Manage interdepartmental regulatory matters and provide regulatory guidance to internal personnel (e.g., executive committee; project teams; clinical, preclinical, and manufacturing departments and subcommittees; etc.)
- Direct interaction with regulatory agencies on defined matters on global level. Build and maintain excellent relationships with FDA personnel and representatives from corporate partners
- Provide regulatory guidance and train peers
You are a part of
- Master’s degree with a minimum of 8 years of experience in regulatory affairs
- At least 5 years of experience in medical device company managing regulatory submission processes with global authorities (EU, Brazil, US, Canada).
- Must have experience with successful preparation and submission of 510 (k), pre-submissions, and all supportive amendments or supplements
- Excellent working knowledge of medical device regulations: ISO 13485, FDA Law (21CFR 820), EU MDR, other global laws and regulations.
- Good experience on HIPAA Security Rule compliance
- Experience in supporting international registrations and clinical investigations
- Ability to creatively complete activities within the allotted, sometimes aggressive, time schedules
- Ability to work either independently with minimal direction separately or within project teams, committees, etc. to attain group goals
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
- Well organized, detail oriented, effective written and oral communication skills, and good grammatical skills
- Good English skill is required, good Chinses language skill is a plus.
In return, we offer you
- We welcome you to a challenging, innovative environment with great opportunities for you to explore.
- We offer competitive compensation and benefits, extensive set of tools to drive your career, such as a personal development budget, free training and coaching, 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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Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven.
Little did they realize that it would become a global force of innovation, committed to
improving billions of lives worldwide. But it did.
Today, Philips is a world leading health technology company with a vision to make life better
for people worldwide through meaningful innovation. Making good on this promise depends on our
passionate, inspirational, collaborative and diverse team.
We have over 80,000+ brilliant people around the world but are always looking for more.
Like-minded, motivated, focused minds to join us in creating a healthier, more connected society
while tranforming themselves personally and professionally.
Working at Philips is more than a job. It's an experience filled with unexcepted moments that
will transform you in lasting and positive ways. Help us improve the world for the better while
building a career that no one could have planned for. Even you.