You will prepare comprehensive regulatory strategies and filings for medical devices new and legacy devices including significant device changes. You will clearly communicate strategies to RA management, core teams, and business unit leadership for device change activity.

　　Your role:

　　Assists regulatory lead in the preparation of robust regulatory applications for Class II or Class III devices (either for FDA, EU, CA or other international regulatory agencies) to achieve departmental and organizational objectives.

　　Provide and maintain documentation support (e.g. annual reports, technical documentation, global dossiers) in collaboration with regulatory lead.

　　Conducts reviews of product and manufacturing changes for compliance with applicable regulations.

　　Acts as a regulatory representative on transformation and sustaining teams, communicates regulatory requirements and impact of regulations to the team.

　　Assists in the development of best practices for regulatory affairs processes.

　　Maintains regulatory databases as assigned.

　　Work with regulatory lead to support product release process.

　　Reviews protocols and reports to support regulatory submissions.

　　Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and regulatory transformation.

　　Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

　　You're the right fit if:

　　You’ve acquired 3+ years of experience in regulatory affairs and submittal experience.

　　Your skills include proficient knowledge of domestic and international standards, strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision; RAPs RAC strongly preferred; you have an understanding of LEAN concepts, methodologies and deployment.

　　You have a Bachelors degree or Masters degree is Regulatory Affairs and/or a science related filed or equivalent years of experience in the medical device industry

　　You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

　　You’re an self-starter and have the ability to Maintains positive and cooperative communications and collaboration with all levels of employees.

　　About Philips

　　We 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.

　　Additional Information

　　US 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 must reside in or within commuting distance to Plymouth, MN.

　　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