Sr. Manager Regulatory Affairs
Job TitleSr. Manager Regulatory Affairs
Senior Manager of Regulatory Affairs
In this role, you have the opportunity to
Help build a high growth business that will help improve the lives of millions of people while advancing Philips journey as a global leader in Health Technology.
As Senior Manager of Regulatory Affairs within Business Group Population Health Management, you will guide and support the business and innovation teams in always doing the right thing while developing and marketing our innovative Population Health Management solutions for global market. You will navigate through the landscape of medical and borderline products and create regulatory plans for solutions comprising hardware, software and services.
We have a dynamic and rewarding career opportunity and are looking for an outstanding candidate for the Senior Manager Regulatory Affairs! You will be member of an international team of regulatory professionals who will support you in realizing your goals, and will work closely with the business Q&R and innovation teams.
You are responsible for
- You will ensure compliance with all applicable standards, regulations and safety policies that pertain to product regulatory approval and maintenance on the market. You will interpret regulations and guidelines, provide guidance and represent the Regulatory Affairs department while participating on cross-functional development teams. You will ensure that overall regulatory activities are conducted and documented in accordance with US FDA requirements and guidelines, applicable international requirements and guidelines, and company policies and procedures.
- As Senior Manager of Regulatory Affairs you will:
- Lead all regulatory affairs to ensure that the products and business comply with all regulatory and safety requirements and Philips policies
- Advise business on marketing claims and strategic roadmaps
- Develop strategies for product submissions/registrations in accordance with current worldwide regulations and guidelines in support of primarily Hospital to Home Business Unit.
- Review and approve product release status for new products, marketing materials, product development documentation including but not limited to FMEA's, product risk assessments, test plans and reports, product specifications, product labeling.
- Prepare and oversee as necessary the preparation of FDA submissions: 510K's, IDE's, etc.
- Prepare and oversee as necessary the preparation of European registrations for new or modified products; CE marking, design/technical dossiers, etc.
- Support the preparation of global product submissions
- Set requirements, review and approve product labeling and literature, advertising and promotional materials.
- Maintain technical reports & certifications from regulatory agencies
- Oversee various compliance activities / processes as needed including employee training on regulatory topics.
- Assist and lead other projects with significant regulatory content as required.
- Regulatory representative into Quality System
- Regulatory updates (monitor and report changes to regulations, guidance and standards relevant for your portfolio)
- Represent Philips in international regulatory bodies on specific subjects
- Report and discuss trends in product roadmaps that could require pro-actively lobbying or building up knowledge about requirement or establishing relationships with authorities and/or certification bodies
To succeed in this role, you should have the following skills and experience
- Bachelor's degree in Health Sciences, Biomedical, Software, Electrical, Mechanical or related engineering required. Master's degree desirable
- A minimum of six to nine (6-9) years in the medical device industry, three to five (3-5) of these years must be in a regulatory affairs field
- Medical device experience in US. 510K and IDE submissions
- European CE marking experience. Class IIa/IIb Technical File
- Well-developed organizational skills
- Advanced written and verbal communication skills
- Project management skills
- Ability to work well in a matrix organization, a network oriented mindset and ability to interact with different business functions at all levels
- Proven analytic capabilities and product knowledge
- Conceptual, analytically strong, data driven, and also hands-on
- A strong leader and a team player. You are an excellent communicator and motivator, skilled in managing interpersonal processes
- Courageous and able to continuously challenge the status quo, with a strong desire to improve organizational effectiveness structurally
- Always looking for perfection. You don't accept underperformance or poor results. You have a quality mindset
- ADDITIONAL DESIRABLE QUALIFICATIONS:
- Regulatory Affairs Certification (RAC)
- Previous practical experience in regulatory activities in software as medical device applications
This job requires some travelling (about 10-20%). Primary location is Baltimore.
In return, we offer you
A path towards your most rewarding career. Succeeding in this role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.
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.
Find out more info about Philips at www.philips.com/na/careers
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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