Philips Regulatory Affairs Manager in United States of America - Home Based, Massachusetts
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 fundaments and will be the Q&R specialist within the team, with a primary focus on US and EMEA.
You are responsible for
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 EU technical files, 510(k)s, 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 approval and FDA clearance 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 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
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
A Masters or Bachelor Degree in Engineering, Life Sciences, Quality or Business Management, highly preferred
Minimum of 5 years of Regulatory experience in a manufacturing environment in Medical Device, Pharma or Biotech industry, preferably in healthcare software engineering
Hands on experience and extensive knowledge about regulatory affairs with a class II (US) and IIa/IIb(EU) products, and a thorough understanding of quality principles and practices
Prior experience in software V&V and development
Working knowledge and experience of the EU MDR Is essential
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
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.
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.
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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.
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