International Regulatory Affairs Manager
If you are a Colorado resident and this role is a field-based
or remote role, you may be eligible to receive additional
information about the compensation and benefits for this role,
which we will provide upon request. You may contact
888-367-7223, option 5, for assistance.
In this role, you have the opportunity to
Manage the Regulatory Affairs International Team based in the
USA. The International Regulatory Affairs Manager is a combination
of People and Regulatory roadmap management. You manage your
project RA experts and represent RA in the Project Management team
to ensure compliance with International Markets. You can
expand the global presence of the Philips IGTD product portfolio by
playing a lead regulatory role in new product introduction (NPI)
projects for international markets. In joining our growing
regulatory team, this position will help Philips reach
international product approval goals while ensuring regulatory
compliance is maintained.
You’ll assist in leading a small team and provide strategic
input during product creation process and support in developing the
department’s overall regulatory strategy. At Philips Image Guided
Therapy Systems (IGT-S) the International RA Manager cooperates
closely with Product Development, Medical / Clinical Affairs and
Marketing and Sales.
You are responsible for
- Managing the RA International Leader for the US Based RA
- Driving the transformation of the IGT-D RA International team
in alignment with the Head of RA International
- Implement the regulatory requirements for continuous Market
access in priority countries into the IGT-D processes (MLD and PDLM
- Oversee the regulatory strategies for registration and
compliance of IGT-D therapies and document them into the Regulatory
- Oversee the execution of the Regulatory Plans and implement a
First-time right submission’s culture (for Registrations,
RE-Registrations and Renewals)
- Implement the RIM solution IGT-D is acquiring to manage
International submissions (i.e: RegDesk: we need to make this tool
- Implement an audit-ready culture
- Keep abreast of Regulatory changes, perform regulatory gap
analysis and prepare the communications for Request for Solutions
(RfS) to the Product safety Review Board (PSRB)
- Interface with regulatory agencies and distribution partners as
- Identifying the need for new regulatory procedures and
participating in development and implementation
- Mentoring other regulatory affairs personnel within the
- Other duties as assigned
You are a part of
As a result of Philips renewed dedication to Quality, it has
recently restructured its organization to ensure you and your
department have clear collaboration with Philips Business Group and
Market leadership, and can harness the expertise of five Centers of
Excellence (COEs). These 5 COEs specialize in the following
capabilities: Regulatory & Clinical Affairs, Supplier Quality,
Quality Management System, Quality Assurance & Engineering, and
Compliance & Audit. As part of this new structure, you are
empowered to use your voice and expertise to have a positive impact
on your team, our business, and health technologies that will
improve the health, well-being and care for people around
To succeed in this role, you should have the following skills
- US work authorization is a precondition of employment. The
company will not consider candidates who require sponsorship for a
- Bachelor’s degree or equivalent internationally acquired
qualification preferably in Regulatory Affairs and/or a science
related field or equivalent experience in the medical device
industry (Master’s degree preferred)
- Minimum of 8 years of medical device regulatory
- Demonstrated experience with international regulations,
standards, and regulatory strategy.
- High analytic skills to propose compliant and pragmatic
- Ability to work in a regulated environment in compliance to ISO
- Must be able to review multiple submissions, regulatory
assessment, and strategies for IGT-Success internationally.
- Proven leadership abilities including hands on experience
managing a team working across multiple time zones.
- Ability to lead, inspire, effectively communicate, onboard, and
continuously couch team members is required.
- Ability to drive collaboration, create high level of teamwork,
and evaluate a positive culture cross-functionally.
- Understand LEAN concepts, methodologies and deployment.
(including leading and executing daily management board.)
- Requires strong written, verbal, and interpersonal skills to be
able to effectively compose agency submissions, interface
interdepartmentally and complete assignments with minimal
- Ability to translate and simplify problems of considerable
scope and complexity into manageable tasks with measurable
In return, we offer you
A path towards your most rewarding career. Philips is growing its
marketing capability enterprise wide. Succeeding in this global
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.
Furthermore, Philips University is available to all employees for
learning and development opportunities.
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. Learn more by watching this video.
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.
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
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