Let’s get started
By clicking ‘Next’, I agree to the Terms of Service
and Privacy Policy, and consent to receive emails from Rise
Jobs / Job page
PMS and Vigilance Specialist (x|f|m) - Hybrid image - Rise Careers
Job details

PMS and Vigilance Specialist (x|f|m) - Hybrid

For our Regulatory Affairs Pharma & Systems department within Sartorius Stedim Biotech GmbH we are currently looking for a PMS and Vigilance Specialist (x|f|m) at our headquarters in Goettingen (full-time, with the possibility to work some days remotely). The overall goal for the owner of this role will be to assists the Bioprocess Solutions (BPS) business with fulfilling the Post Market Surveillance and Vigilance tasks defined by the regulatory and internal requirements, related to the BPS core product portfolio (including Medical Devices, IVDs, devices for Food & Beverage as well as Pharmaceutical & Life Science industry).

Grow with usYour Responsibilities

  • Conduct and assist the PMS, PMCF, Vigilance and Recalls (FSCAs) processes according to our processes and documented procedures (as process owner)

  • Further coordinate PMS data gathering and prepare the PMS plans and reports (PSURs), including review & signoff of the documents

  • The more, coordinate the outsourced PMCF activities and communicate with the external PMCF Service Provider

  • Organize PMCF data gathering and internal document reviews for PMCF data and reports, including signoff of the documents as PMS and Vigilance Specialist (x|f|m)

  • Drive the recall process by organizing meetings, creating decision trees, and evaluating potential recalls (FSCAs) and | or reportability of incidents and complaints plus communicate these cases to authorities

  • Responsible for internal and external audits related to PMS, PMCF, Vigilance and Recall topics

  • Review and revise the documented procedures and related documentation for PMS, PMCF, Vigilance and Recalls (FSCAs) as part of process ownership

  • Collaborate with the R&D, Product Management, Quality Assurance and Sales and Marketing Departments to ensure regulatory compliance

What will convince us

  • Successfully completed Master’s degree in Life Science,  Biotechnology, Pharmaceutics, or in a comparable scientific field

  • Several years of experience within the regulatory affairs discipline in a manufacturing environment, experience in pharma or medical device industry

  • Deep knowledge of regulatory requirements for devices | products in the above listed areas and that of electronic data management systems

  • Thorough understanding and ability to apply regulatory guidelines and regulations related to medical devices or products related to biotechnology and pharma industry

  • Ability to develop innovative strategies and creative solutions within the regulatory context

  • Proven analytical skills and technical competence meet strong initiation and organizational skills

  • Attention to detail, ability to appropriately assess risks and proactive, quick learner such as independent worker 

  • Excellent communication skills, with ability to influence and negotiate a successful outcome under global matrix environment

  • Fluent in English, German will be a plus

  • Identification with our values: Sustainability, Openness & Enjoyment

What we offer

As a growing global life science company, stock listed on the DAX and TecDAX, Sartorius offers a wide range of Benefits:

  • Personal and Professional Development: Mentoring, leadership programs, Talent Talks, internal seminar offerings , coaching for managers

  • Work life balance: Remote options, flextime, flexible work schedules, sabbaticals

  • Attractive compensation: Vacation and holiday bonuses including pension benefits with a 35 hr. week, 30 vacation days

  • Large, modern campus: Open office spaces, terraces, company restaurant with vegetarian and vegan options, cozy Italian bistro with ice cream sales, fitness studio and daycare center

  • Making an impact right from the start: Comprehensive onboarding, including a virtual online platform even before joining, Welcome Workshops, "buddy" as point of contact

  • Travel benefits: Car leasing, bike leasing, large free parking garage, good bus connections

  • Welcoming Culture: Mutual support, teamspirit and international collaboration; communities on numerous topics, such as coaching, agile working and business women network

About Sartorius 

Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. 

We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.

Join our global team and become part of the solution. We are looking forward to receiving your application. 
www.sartorius.com/careers

Average salary estimate

$70000 / YEARLY (est.)
min
max
$60000K
$80000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

Similar Jobs

Become a key player in Lockheed Martin Space, driving quality assurance in innovative software solutions for the aerospace domain.

Lead quality improvement initiatives as Market Director for Dignity Health Nevada, a renowned nonprofit healthcare system dedicated to serving communities.

Photo of the Rise User
Customer-Centric
Rapid Growth
Diversity of Opinions
Reward & Recognition
Friends Outside of Work
Inclusive & Diverse
Empathetic
Feedback Forward
Work/Life Harmony
Casual Dress Code
Startup Mindset
Collaboration over Competition
Fast-Paced
Growth & Learning
Open Door Policy
Rise from Within
Maternity Leave
Paternity Leave
Flex-Friendly
Family Coverage (Insurance)
Medical Insurance
Dental Insurance
Vision Insurance
Mental Health Resources
Life insurance
Disability Insurance
Health Savings Account (HSA)
Flexible Spending Account (FSA)
401K Matching
Paid Holidays
Paid Sick Days
Paid Time-Off

Join Concorde Battery Corporation as a CMM Programmer/Quality Control Inspector and contribute to ensuring the highest quality in battery manufacturing for the aviation sector.

Photo of the Rise User
Providence Health & Services Remote US, Multnomah County, OR; Oregon State, Portland, OR
Posted 14 days ago

We are looking for a Quality Assurance RN to enhance healthcare quality initiatives at Providence, focusing on patient care and compliance.

Posted 16 hours ago

Maconsofts is on the hunt for a Senior QA Analyst to champion user acceptance testing and drive alternative business solutions remotely from anywhere in the United States.

Photo of the Rise User
PA Consulting Hybrid Tower Point, 6th Floor, 27-43 Wormwood Street, Boston, MA 02210, United States of America, Boston
Posted 13 days ago

Be part of a dynamic team as a Quality Assurance Engineer at PA, focusing on building quality standards for health data platforms.

Photo of the Rise User
Nimble Remote Chesterfield, Missouri, United States
Posted 12 days ago

Nimble Solutions is on the lookout for a Quality Assurance Analyst to drive compliance and accuracy in accounts receivable claims while enhancing team performance.

Emanuel Medical Ctr Hybrid US, Stanislaus County, CA; California, Turlock, CA
Posted 8 days ago

Join Emanuel Medical Center as a RN Quality Patient Safety Officer and lead efforts in patient safety and quality improvement in healthcare.

Photo of the Rise User
Posted 2 months ago
Photo of the Rise User
Inclusive & Diverse
Rise from Within
Mission Driven
Diversity of Opinions
Work/Life Harmony
Customer-Centric
Fast-Paced
Growth & Learning
Medical Insurance
Dental Insurance
401K Matching
Paid Time-Off
Maternity Leave
Paternity Leave
Mental Health Resources
Flex-Friendly

As a growing global life science company and a dynamic industry leader, Sartorius is the go-to place for ambitious people who want to move things forward: We offer you the chance to grow with us and to become part of the solution in the fight agai...

19 jobs
MATCH
VIEW MATCH
FUNDING
SENIORITY LEVEL REQUIREMENT
TEAM SIZE
EMPLOYMENT TYPE
Full-time, hybrid
DATE POSTED
April 18, 2025

Subscribe to Rise newsletter

Risa star 🔮 Hi, I'm Risa! Your AI
Career Copilot
Want to see a list of jobs tailored to
you, just ask me below!
LATEST ACTIVITY
Photo of the Rise User
Someone from OH, Euclid just viewed Technical Account Manager at ZeroFOX
Photo of the Rise User
Someone from OH, Euclid just viewed Technical Account Manager (Enterprise) at Rippling
Photo of the Rise User
Someone from OH, Euclid just viewed Software Engineer (Node.js & AWS) at Litify
Photo of the Rise User
Someone from OH, Euclid just viewed Technical Program Manager at DeepSource Technologies
Photo of the Rise User
Someone from OH, Euclid just viewed Solution Engineer, Amazon Connect at NeuraFlash
G
Someone from OH, Dublin just viewed Outside Sales Representative at Go Flooring, LLC.
W
12 people applied to QA Engineer at WhiteTech
M
Someone from OH, Cincinnati just viewed Remote Data Entry Operator at MUTW, LLC