Sep 19, 2019Full time
Regulatory Affairs Manager United States of America – Home Based Full time 330377 Job Title Regulatory Affairs Manager Job Description 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. Likewise, 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 RA expert specialist within the team, with a primary focus on the US and Asia Pacific Regulatory Affairs You are responsible for Preparing US and international regulatory filings (APAC, other) to obtain regulatory to meet the company’s plans for commercialization of new and modified devices. This includes preparation of 510(k)s (mainly), letters to file and compilation of international registration documentation. Setting regulatory strategy for worldwide distribution. Participating in product development teams and provide regulatory strategy, identify and resolve regulatory questions throughout product development process to assure successful regulatory filings. Participating in regulatory inspection activities with regulatory agencies. Assisting 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 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 Lead of EPD in the US. To succeed in this role, you should have the following skills and experience Bachelors Degree (Masters Degree preferred) in Engineering, Life Sciences, Quality or Business Management, Experience working in the medical device industry in similar roles 5+ years of Regulatory experience in EP ablation technology in the cardiac arrhythmia treatment domain Extensive knowledge about regulatory affairs with a class I and II (US) and Asia Pacific, specifically China. Experience with class I and IIa (EU) products preferred. 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 Ability to work with a multicultural, diverse global team 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. It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.