Regulatory Affairs Manager
Company: Philips Electronics North America Corporation
Location: Colorado Springs
Posted on: October 3, 2021
Regulatory Affairs Manager
In this role, you have the opportunity to
Lead individual contributors, generally operating from junior to
senior level, formulating regulatory strategic plans, while also
being involved in developing, modifying and executing company
regulatory strategies and policies that affect immediate
You are responsible for
- Leads business unit regulatory resources to ensure timely
product registrations, regulatory planning for new product
introductions and product changes, guidance on risk assessment, and
required corrective actions to meet regulatory requirements, as
well as leadership and guidance on core market regulatory strategy,
such as US, EU, Canada, Japan, and China.
- Exercises supervision in terms of budgets, schedules, methods,
staffing and performance. Establishes operational objectives
and work plans, and delegates assignments to Regulatory Specialist
- Works on issues where analysis of situations or data requires
an in-depth knowledge of organizational objectives.
- Involved in developing, modifying and executing company
regulatory policies that affect immediate operations.
- Regularly interacts with Regulatory management on matters
concerning several functional areas and/or customers.
- Responsible for product registrations/approvals.
- Responsible for working with Site and Business Leadership to
complete compliance with new EU MDR (Medical Device
- Monitor current regulatory procedures and changes. Participates
in direct interaction with regulatory agencies on defined
- Recommend and develop strategies and create detailed written
- Identify potential regulatory approvals risks based on changes
in regulations, standards country specific issues or other unique
characteristics of the project.
- Drives improvement in regulatory aspects of the Quality System,
developing processes and documenting procedures to ensure an
effective Quality System.
- Responsible for ensuring compliance with regulatory procedures
and updating the procedures when new regulatory requirements become
- Advise internal stakeholders (marketing, manufacturing,
R&D, etc.) regarding current/pending guidance, regulations,
Agency/industry initiatives, etc. to ensure regulatory strategy is
in alignment with company objectives.
- May review and approve advertising, promotional items and
labeling for regulatory compliance.
- Develop talent and build up Regulatory as a value–added
- Maintain regulatory files and tracking databases as
- Must ensure that training assignments remain current.
You are a part of
Our solutions combine navigational tools such as catheters
and guide wires with advanced software to help confirm the optimal
treatment at the point of care: measurement
technology, procedure-specific application support and
on-board imaging and monitoring with improved anatomical and
functional information to optimize therapy delivery. ?? The
IGT Devices organization consists of three segments:
Coronary, Peripheral Vascular and
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 preferably in Regulatory Affairs and/or a
science related field or equivalent experience in the medical
- Minimum of 8 years of experience in the medical device industry
(EU MDD, US FDA class II, class III) or 12 years of regulatory
experience if the candidate’s background does not include class III
- Must have personal “hands on” experience with successful
preparation, submission and clearance of 510(k)s. Regulatory
& technical competency is also expected with CE marking / technical
files experience is strongly preferred.
- Experience in supporting international registrations, clinical
investigations and clinical evaluation reports.
- Strong background in Design Controls and Risk Management
- Proficient knowledge of medical device regulations (21CFR),
MDD/EU MDR, MDSAP and other global laws and regulations and
- May require occasional travel
In return, we offer you
The salary range for this position is: 130-155k. The bonus
target is: 15%
Our benefits can be found here: https://www.careers.philips.com/na/en/total-rewards-at-philips.
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
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
If you forgot your password, you can click
the Forgot Password button on the Sign In
screen to reset it.
Keywords: Philips Electronics North America Corporation, Colorado Springs , Regulatory Affairs Manager, Other , Colorado Springs, Colorado
Didn't find what you're looking for? Search again!