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The Principal Regulatory Affairs Specialist will work within our Sleep & Respiratory Care business group working with the home and hospital care ventilator products and activities related to new product introductions and sustaining activities.In this role you will be responsible for:
This role will allow the opportunity to author 510(k) submissions, as well as technical file submissions for EUMDR and Health Canada.
This role sits within a team of 6-8 regulatory personnel and requires a candidate who can train junior members and new hires on submission procedures in the future.
This role will have minimal travel (up to 10% annually) dependent upon audit support needed. Candidates must be able to work in a hybrid capacity onsite 3 days per week, and 2 days remote at either our Cambridge, Pittsburgh, or Plymouth location.
You're the right fit if:
You’ve acquired 5+ years of experience in authoring 510(k) submissions in the medical device industry. Experience working regulatory bodies related to FDA, Health Canada, and EUMDR submissions. Experience with both new product introductions and sustaining activities is preferred.
Your skills include 510(k) submission experience, familiarity with acceptable regulatory standards per country, and ability to work within a team setting, at times leading the process.
You have a Master’s degree in an Engineering or related field preferred, or Bachelor’s degree with 7+ years related experience. RAC preferred.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
You’re an experienced regulatory professional with the ability to provide guidance related to submissions to the FDA, EUMDR, and Health Canada regulatory bodies. You are a team player looking to join a supportive and cohesive unit.
Have experience submitting and maintaining technical documents files for EU Class l, lla and llb medical devices, preferably with consumable accessories.
Have experience with Regulatory sustaining activities including change assessment, technical file updates, letter to file, GSPR, AU EP, Declaration of Conformity.
Have been involved in EU MDR, MDSAP and ISO 13485 audits.
You have successfully supported the transition of class lla, llb or III devices from MDD to MDR through Notified Body review.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position (https://www.careers.philips.com/na/en/office/remote-sedentary-work-physical,-cognitive-and-environmental-pce-job-requirements) .
About PhilipsWe are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
Learn more about our business (https://www.philips.com/a-w/about.html) .
Discover our rich and exciting history. (https://www.philips.com/a-w/about/our-history.html)
Learn more about our purpose. (https://www.philips.com/a-w/about/environmental-social-governance/our-purpose)
Read more about our employee benefits (https://www.careers.philips.com/na/en/best-employee-benefits) .
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here (https://www.careers.philips.com/global/en/diversity-and-inclusion) .Additional InformationUS work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.Company relocation benefits will not be provided for this position. For this position, you will reside in or within commuting distance to Cambridge, MA., Plymouth, MN., Pittsburgh, PA., or Milford, CT. USA.It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.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.Equal Employment and Opportunity Employer/Disabled/Veteran
