Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
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As one of the largest biotechnology companies in Germany, we research, develop and produce innovative biomarker diagnostics and distribute our products in more than 65 countries. B• R• A• H• M• S is based in Hennigsdorf near Berlin, which is home to about 285 of the company's 550 employees worldwide.
Driving the value of innovation, the Clinical Diagnostics Division is known as an industry-leading provider and a trusted partner for in-vitro diagnostics products and services. There are over 3,000 products manufactured at key centers of excellence around the world.
For the Biomarker Business Unit we are looking for a
Global Product Compliance Manager (m/f/d)
Location: Hennigsdorf, Germany
When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding new diagnostic tools and improving patient management. Your work will have real-world impact, and you'll be supported in achieving your career goals. Our staff members are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with proven competencies and strong character to help lead our organization now and into the future.
How will you make an impact?
The Thermo Fisher Scientific Biomarkers Global Product Management team is positioned to support our clients gaining access to critical diagnostic equipment. Our teams focus on evaluating new business opportunities in worldwide markets, and product launches. Our organization is designed to enable visibility with business leadership and to empower you to strategically plan and implement the future of our organization.
What will you do?
Our product strategy is crafted to provide you experiences in understanding global markets and the responsibility of growing one Thermo Fisher's product segments. Responsibilities are inclusive but not limited to:
- Develop and maintain product related quality documentation to ensure accuracy and compliance with industry standards and regulations
- Own IFUs/package inserts to be compliant with the latest product modifications and enhancements.
- Develop, review, and update Product Management related SOPs to ensure clarity, accuracy, and alignment with current practices.
- Own product management activities related to CAPAs and change controls in conjunction with all departments
- Develop a regulatory commercial strategy and owning process registration prioritization
- Drive and track project plan and deliverables and report project progress, problems and solutions using appropriate tools.
- Report on return on investment and key performance metrics on product management activities by establishing KPIs (leading and lagging indicators), as well as monitoring and reporting progress on a routine basis.
Education:
- Master's degree in engineering, Chemistry, Biology or related sciences. (MBA Preferred)
- Quality assurance or Regulatory background (i.e. internal auditor) preferred
- Work experience with IVD systems, diagnostics, medical device or other healthcare in regulated environments is strongly preferred
- Strong quantitative, analytical, and problem-solving skills.
- Results oriented through initiative, ownership, and accountability.
- Excellent interpersonal, verbal and written presentation skills in English
What we offer:
- Employment with an innovative, future-oriented organisation
- Outstanding career and development prospects
- Company pension scheme and other fringe benefits
- Exciting company culture which stands for integrity, intensity, involvement and innovation
If you are interested, please apply online with your CV and Motivation Letter including possible start date and salary expectations.
At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or any other legally protected status.
Apply today! http://jobs.thermofisher.com
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