Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.In this role you have the opportunity toThis Sr Regulatory Affairs opportunity will be responsible for planning, authoring, and maintaining US and other major market medical device submissions for Philips IGTD's Coronary Vascular business. This includes related department operations initiatives and compliance-related efforts.Your role:
Preparing global regulatory strategies for new devices and post market changes. Clearly communicates strategies to RA management and core teams.
Preparing regulatory submissions (e.g. 510K, CE Techincial Document for new products, as well as significant post market changes. As necessary, reviews complex regulatory issues with RA manager.
Providing accurate and consistent regulatory recommendations, decisions, and feedback to product development and manufacturing teams.
Identify risks within regulatory strategies and clearly communicate risks to projects teams and RA management Negotiate and lead meeting (eg Pre-Subs) directly with government entities (e.g. FDA, Notified Bodies, etc.) on regulatory filings at the reviewer level.
Following Quality System procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR, CMDR, MDSAP and all other applicable regulations.
Maintaining proficiency in broad, regional regulatory requirements. Develop general strategies on more effective interactions with government agencies and agency personnel.
Training of more junior specialist staff.
You're the right fit if:US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.BS degree in a relevant field5+ years of medical device experience with BS degree, and work experience in regulatory affairsStrong oral and writing skillsDemonstrated experience in multiple types of substantive regulatory filingsMust have a working knowledge of FDA, ISO, EU, and other applicable regional regulations for handling complaints, reporting incidents, and implementing corrective and preventive actionsKnowledge of PC hardware/software, documentation and archivesAbout 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.
Discover our rich and exciting history.
Learn more about our purpose.
Read more about our 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.Philips Transparency DetailsThe pay range for this position is $77,000 to $143,000, Annually. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.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.#LI-PHI#LI-HYBRIDIt 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