Regulatory Affairs Manager
- United States of America – Home Based
- Full time
In this role, you have the opportunity to
join a fast-growing Philips venture, with the potential to disrupt a billion dollar industry and touch millions of lives by developing a unique medical device solution. You will have the opportunity to work with a very entrepreneurial venture organization and support the growth of this organization with the right fundamentals and will be the Q&R specialist within the team, with a primary focus on US Regulatory Affairs.
You are responsible to
- Prepare domestic and international regulatory filings to obtain regulatory to meet the company’s plans for commercialization of new and modified devices. This includes preparation of 510(k)s (mainly), EU technical files, letters to file and compilation of international registration documentation.
- Participate in product development teams and provide regulatory strategy, identify and resolve regulatory questions throughout product development process to assure successful regulatory filings.
- Participate in regulatory inspection activities with regulatory agencies.
- Assist organization in planning for compliance with EU MDR and other evolving and new regulations and standards.
You are a part of
Philips EPD Solutions, a recently acquired venture with ambitious plans for growth, developing a disruptive technology, which will improve the efficiency and efficacy of life-saving cardiac ablation procedures treating among others atrial fibrillation. EPD’s technology has the potential to address the key unmet need of real-time therapy assessment, which is one of the more significant limitations of the current standard of care. We aim to help to improve outcomes for millions of people and help maintain the rapidly rising cost of managing the disease. Having obtained CE mark and FDA approval in 2018, we are preparing for a commercial product launch in Europe, US, and other territories and are seeking regulatory approvals around the world.
You will be based in the US, have many interfaces with the corporate Q&R team in Best, the R&D team in Israel and you will be reporting into the global Q&R Manager of EPD in the US.
To succeed in this role, you should have the following skills and experience
- A Masters or Bachelor Degree in Engineering, Life Sciences, Quality or Business Management, preferably with experience working in a highly regulated business
- Minimum of 5 years of Regulatory experience in EP ablation technology in the cardiac arrhythmia treatment domain
- Extensive knowledge about regulatory affairs with a class II (US) and preferably IIa (EU) products, and a thorough understanding of quality principles and practices
- Knowledgeable about FDA regulations and international regulatory requirements
- Excellent verbal and written communication skills in English
- Strong verbal and writing skills and good interpersonal and leadership skills
- Excellent organizational skills and ability to execute on multiple priorities in a fast paced environment
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
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.
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.