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International Regulatory Affairs Manager

Company: Philips Electronics North America Corporation
Location: San Diego
Posted on: October 13, 2021

Job Description:

Job Title

International Regulatory Affairs Manager

Job Description

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 International Group
  • 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 processes)
  • Oversee the regulatory strategies for registration and compliance of IGT-D therapies and document them into the Regulatory Plans
  • 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 ours.)
  • 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 needed
  • Identifying the need for new regulatory procedures and participating in development and implementation
  • Mentoring other regulatory affairs personnel within the business
  • 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 world.

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 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 experience.
  • Demonstrated experience with international regulations, standards, and regulatory strategy.
  • High analytic skills to propose compliant and pragmatic regulatory strategies 
  • Ability to work in a regulated environment in compliance to ISO 13485
  • 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 supervision.
  • Ability to translate and simplify problems of considerable scope and complexity into manageable tasks with measurable requirements

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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Keywords: Philips Electronics North America Corporation, San Diego , International Regulatory Affairs Manager, Other , San Diego, California

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