Regulatory Labeling at Stryker

Freiburg, Baden-Wurttemberg, Germany

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Quality Management, Engineering, or a related field
Minimum 2 years of experience in label data management, regulatory, or quality functions within a highly regulated industry (e.g. medical device, pharmaceutical, or food)
Hands-on experience with labeling or quality software such as Prisym, Robar, Bartender, or similar
Proficiency in Microsoft Suite (Excel, Power BI, etc.)
Excellent English communication skills, enabling effective collaboration with global and local stakeholders
Preferred: German language skills
Preferred: Strong project management abilities and experience leading cross-functional collaboration
Preferred: Familiarity with EU MDR, ISO 13485, FDA 21 CFR Part 820, and other global quality standards

Responsibilities

Manage product label and UDI data changes in compliance with relevant QMS processes
Collaborate with stakeholders to gather, transform, and verify accurate label content
Maintain and update labeling procedures to ensure regulatory compliance and operational efficiency
Partner closely with internal “label customers” to support departmental and business needs
Lead or contribute to continuous improvement initiatives in Label Development and standardization
Investigate and resolve non-conformance issues with internal teams and suppliers, implementing effective corrective actions
Support the design, testing, and implementation of labeling software tools and systems
Train and support end users on labeling processes and tools to promote best practices

Skills

UDI compliance

label data management

regulatory compliance

QMS processes

Prisym

Robar

labeling software

continuous improvement

corrective actions

stakeholder collaboration

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Medical & prescription plans

Supplemental health benefits

Flexible Spending accounts

Employee Assistance Program

Short-term & long-term disability

Tuition reimbursement

401(k) plan

Employee Stock Purchase Plan

Risks

Integration challenges from acquisitions may strain Stryker's resources.

Rapid tech advancements risk obsolescence of Stryker's current products.

Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.

Entry into the peripheral vascular segment diversifies Stryker's market presence.

Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.

The orthopedic implants market growth benefits Stryker's expanding product line.

Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

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