Philips Principal Ultrasound Regulatory Affairs Specialist 

South Africa, Free State, Dihlabeng Local Municipality 

375535543

Principal Ultrasound Regulatory Affairs Specialist
Job Description

The Program Manager provides operational leadership of programs, and are accountable for the development, delivery, and scheduling of projects in support of the Ultrasound Regulatory organization.

Your Role:

• This role will oversee a variety of different programs within Ultrasound Regulatory Affairs; and will drive these programs from inception to completion. You must be able to lead and coordinate program activities and resources across the program scope to enhance efficiency and effectiveness.
• This role is responsible for gaining agreements on and achieving program goals and objectives, balancing, and managing the program scope (including requirements), schedule, budget, quality, resources, and risks. You must be able to manage and monitor program and project activities, proactively assessing and responding to risks, spanning multiple projects.
• This role is responsible for maintaining project data necessary to understand assumptions made, progress made, and issues or risks associated with the projects. Organizes the archives of project information.
• You must be able to influence without authority, take accountability for results, display empathy and respect towards self and colleagues, and build consensus and community during completion efforts. The ideal candidate will operate with transparency, lead by example, and leverage their critical and situational thinking skills to maximize operational efficiencies. The ideal candidate will also have an ongoing passion for learning.
• This is an independent contributor type role with no direct reports; however, you will be managing a portfolio of projects and indirectly the people working on those projects as you are held accountable for the results. This role is expected to build partnerships with the program’s stakeholders (both internal and external), leverage them to achieve organizational goals, and be able to influence their opinions and negotiate effective solutions.

You are the right fit if:

• You have acquired 5+ years of experience in program management within the medical device industry. PMP certification is a plus but not required. Will consider an equivalent combination of education and relevant work experience. Medical device regulatory experience required with experience with US and global medical device regulations and submissions. Experience working in a broader enterprise/cross division business unit model preferred.
• Your skills include strong knowledge of medical device regulations (e.g., FDA 21 CFR Part 820, ISO 13485); proven history of successfully managing cross-functional teams and complex projects; ability to work autonomously and problem solve as needed.
• Demonstrated record of leading teams across different functions/divisions. Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
• You can work in a highly matrixed and geographically diverse business environment. You can work effectively within a team in a fast-paced changing environment, have strong verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization. Able to multi-task, prioritize and meet deadlines in a timely manner. Has strong organizational, planning, and follow-up skills and ability to hold others accountable.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

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