Regulatory Affairs Manager

Company: Philips Electronics North America Corporation
Location: Colorado Springs
Posted on: October 3, 2021

Job Description:

Job Title

Job Description

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 operations.

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 Team.
• 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 Regulation).
• Monitor current regulatory procedures and changes. Participates in direct interaction with regulatory agencies on defined matters.
• Recommend and develop strategies and create detailed written regulatory plans
• 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 effective.
• 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 business partner.
• Maintain regulatory files and tracking databases as required.
• 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 Electrophysiology.

To succeed in this role, you should have the following skills and experience

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
• Bachelor’s degree preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry.
• 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 devices.
• 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 standards.
• 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

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

#LI-PH1

Contact

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