Sr. Program Manager
Sr. Program Manager
In this role, you have the opportunity to
Work for a progressive and dynamic company within the medical device industry in a challenging global regulatory environment, develop and communicate a vision for the RA function to management, including the development of global regulatory strategy in the area of regulatory submission.
We are a mature and dynamic organization that is rapidly growing and needs strong Program Mangers to achieve our growth ambitions. Be a part of team that makes a difference. We deliver technology that improves the lives of people around the world, every day. Ultrasound is a business of critical importance in Philips, delivering meaningful innovation in a competitive environment.
We are looking for a leader with functional experience in Quality and Regulatory, with a record of accomplishment driving cross-functional teams. Ideal candidate can demonstrate successful leadership with an eye for continuous improvement, preferably within Medical Device or similar regulated businesses. Projects are part of value creation, delivering to long-term growth and Philips' ambition to reach 3 billion consumers globally. Program Managers are a leadership group that engages the global organization in projects, managing the collective relationships between and among the stakeholders, team members, and business results, instilling confidence of the organization in the future of the business through consistent results.
You are responsible for
- Lead and provide regulatory project management support on various business critical programs;
- Work closely with the cross-functional program team, including regulatory leaders on design, development and manufacturing transfer programs;
- As a Program Manager, you will provide project management support various Philips Ultrasound projects requiring mapping, monitoring and reporting of all critical activities to both internal and external stakeholders;
- Will apply best practices and the team’s talents to add value to the business, through successfully completing projects and driving learning and improvement;
- Lead business critical projects and provide regulatory oversight to maintain lifecycle ensuring that the state of the art requirements are maintained;
- Driving improvement in regulatory aspects of the Quality Management System and in developing relevant regulatory processes and documenting procedures to ensure an effective Quality System is maintained;
- Ensuring compliance with the current regulatory procedures and the procedures when new regulatory requirements are determined to go into effect;
- Advising on regulatory policy (for market release) in line with Philips regulatory policy;
- Product Development portfolio: Provide timely regulatory support to the planned Philips product development efforts to assure on time product release per project timelines;
- Regulatory Compliance: Lead all compliance related activities, including simplification and Harmonization of regulatory procedures;
- Metrics: Develop and implement appropriate quality and regulatory metrics to facilitate tracking and monitoring of key element of the quality system, compliance, and regulatory activities.
- Able to identify risks within regulatory strategies, project plan, and outline proposal for balancing the project risks to projects teams and RA management;
- Driving improvement in regulatory aspects of the Quality Management System and in developing processes and documenting procedures to ensure an effective Quality System is maintained;
- Ensuring compliance with the current regulatory procedures and where needed, generate new and/or update procedures when new regulatory requirements are determined to go into effect;
- Where applicable, represent Philips in an international committee chartered to develop an applicable standard;
- As needed, you will represent Philips Ultrasound Regulatory Organization in both internal audits and external audits by various key market regulatory agencies, including inspections and surveillance visits by Notified Body;
- Mentor and coach Philips Ultrasound regulatory professionals in their development;
- Travel 10-15%;
You are a part of
You are a part of Philips Regulatory Affairs Organization with a global footprint. The Regulatory Affairs team is multicultural and are enthusiastic professionals that work as a team to ensure regulatory compliance.
To succeed in this role, you should have the following skills and experience
- Bachelor or Advanced Degree in engineering or scientific field of study.
- 8+ years of Regulatory Affairs or Quality experience in the Medical Device industry or related industry is required.
- 8+ years of project management experience, PMI certification preferred, but not required
- First line experience with US FDA, China NMPA and EU MDD/MDR is preferred;
- Experience with Software as Medical Devices, and Ultrasound Imaging Devices is preferred;
- Product development experience (End2End), preferably in medical devices with regulatory considerations;
- Cross-functional team management experience in a matrix organization;
- Team player who can work in a matrixed environment with teams in different locations;
- Ability to manage projects with tight time, cost and quality targets;
- Effective presentation and interpersonal skills;
- Strong analytical/problem solving skills;
- Excellent English verbal and written communication skills and Mandarin preferred;
- Results oriented with focus on achieving overall business objective;
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.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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.
If you forgot your password, you can click the Forgot Password button on the Sign In screen to reset it.
If you have any other questions regarding the recruitment process please refer to our FAQs. In case of technical difficulties with the website, please send an email to email@example.com.
(Note: To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)