Regulatory Project Manager
In this role, you have the opportunity to
Provide Regulatory Affairs Support for New Product Development and Sustaining efforts in both the domestic and international markets for assigned medical devices. You will work as a Regulatory Affairs Engineer on problems of diverse scope where analysis of regulatory data requires evaluation of identifiable factors. The development of the solution requires a multi-disciplinary approach and knowledge of regulatory principles, theories and concepts.
You are responsible for
Working independently on the Regulatory duties, processes and roles outlined below:
Lead Project teams for Regulatory Projects with Business Unit Impact, to include the management of project team personnel, the development of an executable Quality Plan, coordination with partnering functions/departments/resources and the management of the associated schedule and budget.
Lead special regulatory projects and process improvement projects, including developing project plans and monitoring progress and completion for regulatory activities
Lead review for new and revised guidance's, regulations and standards
Participates on New Product Development Team for assigned products. Creates and executes Regulatory Strategies and Plans in the Domestic, Mature, and Emerging Markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers.
Design History File, Technical File and Declaration of Conformity (MDD, MDR, RED, RoHS, etc) creation, review, and approval
Regulatory assessment of Engineering Changes and Regulatory Assessment Checklist completion
New Product Licensing and Registration submissions in the Domestic and Mature Markets (US, EU, CAN, AU)
Create and/or lift Regulatory Restrictions based on the Regulatory status of assigned products
German Reimbursement submissions
Provides document support to the Emerging Markets team for international product registration
Reviews and approves product labeling plans, labels, and marketing communications
Drafts Standards Requirements Document
Mentors Regulatory team members
Directly supports and interfaces with Internal and External Quality Audits as a Subject Matter Expert
Addresses customer related concerns regarding the RA process for our products
Interfaces with Business Unit functions as needed to resolve regulatory concerns
Tracks pending domestic and global regulatory changes, develops and executes quality plans to minimize impact to the Business Unit
Maintains expertise in domestic and foreign regulations and standards, with a focus on assigned products and regional focus on the US (FDA), EU (MDD and/or MDR), CA (Health Canada), and AU (TGA).
Provides Regulatory Training to business units on regulations and standards as they apply to assigned products / business units.
Conducts Regulatory Intelligence Analysis on specific assigned regions or content and briefs the business unit Regulatory Teams on results.
At Philips we are passionate about improving quality of life with solutions designed around the needs of customers and their patients. Innovation is driven by gaining insight to the needs of the people who use our sleep and respiratory solutions. This tradition of innovation, combined with our ability to anticipate market needs, has made Philips a global leader in the markets we serve.
Here at Philips WE ARE Working Together for a Better Tomorrow
Philips' dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people. Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.
Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what's next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.
Thanks to our employees, we are at the forefront of the Healthcare industry. Healthcare providers, backed by our many market leading solutions, are able to diagnose confidently, improve care, and increase the quality of life for patients across North America each and every day.
To succeed in this role, you should have the following skills and experience
B.S. or B.A in engineering or science discipline or equivalent required. Advanced degrees or certifications preferred. Project Management Certification (PMP) preferred. 7+ years of experience in Medical Device. 3+ years of experience in Project Management.
The successful candidate will have:
Knowledge in the area of FDA procedures and practices, a working knowledge of medical device regulations, and experience in the medical device industry. Has basic knowledge of related disciplines.
Ability to carry out successful interactions and negotiations experience with FDA premarket notification submittals and experience interacting with FDA.
Knowledge in the area of the Quality System Regulation, the EU Medical Devices Directive and/or Medical Device Regulations, Canadian Medical Device Regulations and other national and international regulations.
Ability to formulate the solution for (technical) partial problems that cannot be found by combining previous experiences but by composing newly acquired regulatory knowledge. Ability to apply advanced regulatory process principals to multiple tasks and introduce regulatory methods/procedures that are new for the organization.
Works independently, and may lead multi-disciplinary regulatory change projects, managing a number of team members' support of the project.
Excellent technical writing and verbal communication skills.
Ready to start improving lives by putting your personal skills & passions to work? Apply Today! Not yet ready to apply? That's okay! Learn more about us by joining our Talent Network on LinkedIn or following us on Twitter at @PhilipsJobsNA.
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
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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