Senior Regulatory Affairs Specialist

Stryker; Schönkirchen; On-site; EUR 60,000 - 105,000; Full time

Job summary

Stryker is seeking a Senior Regulatory Affairs Specialist to lead post‑market surveillance activities for the GSA region, including investigations, field actions, complaints and regulatory compliance.

You will collaborate with RAQA, Quality, Supply Chain and Customer Service, manage PMS metrics and drive improvements in post‑market processes in a global matrix. You will also support regulatory inspections and keep stakeholders informed of risk and timelines.

Qualifications

• Post-market surveillance and regulatory compliance in medical devices.
• Experience in handling PMS, complaints and field actions.
• Experience in a cross-functional, international matrix organization.

Responsibilities

• Executes post-market surveillance activities with focus on Complaint Handling and Product Field Actions.
• Coordinates intake, processing, follow-up and closure of product complaints with proper documentation.
• Coordinates local execution of Product Field Actions and recalls including communication and closure.
• Reviews product scope, distribution and inventory information and coordinates actions with stakeholders.
• Acts as interface between RAQA, PMS, Legal, Customer Service, Sales and Supply Chain.
• Supports communication with authorities and external stakeholders on PMS matters.

Skills

Regulatory affairs

Quality assurance

Post-market surveillance

Cross-functional teamwork

German & English fluency

Education

BSc in Engineering/Regulatory Affairs/Quality Management

Tools

TrackWise

MS Office

Job description

Join our team as a Senior Regulatory Affairs Specialist!

This person will for a key part of our Regulatory Affairs function, servicing the GSA region and will be exposed to a broad range of Stryker products.

Do you have a strong understanding of regulatory framewrok? Are you looking for a challenging role that will push your knowledge in this sector?

Key Areas of Responsibility:

• Executes post-market surveillance activities with focus on Complaint Handling, Product Field Actions (PFA/FSCA), Commercial Holds and related Post Market activities (PMS) activities.
• Coordinates the intake, processing, follow-up and closure of product complaints and ensures complete and timely documentation in applicable quality systems.
• Coordinates local execution of Product Field Actions, recalls and Commercial Holds, including assessment of local impact, containment, customer communication, reconciliation, product return/destruction and closure activities.
• Reviews product scope, distribution and inventory information and coordinates required actions with relevant local, regional and divisional stakeholders.
• Acts as an operational interface between RAQA, Central/Regional PMS, Legal Manufacturers/Divisions, Customer Service, Sales, Supply Chain, Distribution/Warehouse and other relevant stakeholders.
• Proactively coordinates and follows up on outstanding actions, clarifies responsibilities, and escalates delays, gaps or compliance risks as appropriate.
• Supports communication with Competent Authorities and other external stakeholders on post-market surveillance matters.
• Maintains systems to track, manage and report product complaints, field actions, Commercial Holds and other product-associated events.
• Monitors assigned cases, timelines and execution status and ensures activities are completed in line with applicable procedures and defined timelines.
• Supports complaint trending
• Monitors the post-market environment, including applicable regulations, guidance and other relevant information.
• Supports the development, implementation and continuous improvement of PMS procedures, SOPs, work instructions and training materials.
• Provides PMS process guidance and operational support to internal stakeholders and promotes awareness and understanding of Complaint Handling and PFA/HOLD processes.
• Supports preparation for regulatory inspections, internal and external audits and other PMS-related assessments.
• Prepares and monitors RAQA/PMS metrics and KPIs and supports identification of trends, backlogs and opportunities for continuous improvement
• Identifies opportunities to improve the effectiveness and efficiency of PMS processes and supports implementation of improvement activities across RAQA.

Education / Work Experience:

• BSc in Engineering, Science, Regulatory Affairs, Quality Management, Business Administration or related degree; equivalent relevant professional experience may be considered.
• 2+ years’ relevant experience in Regulatory Affairs, Quality Assurance, Post-Market Surveillance, Complaint Handling or another regulated medical-device environment.
• Experience working in a cross-functional and international matrix organization preferred.

Knowledge / Competencies:

• Good understanding of Post-Market Surveillance, Complaint Handling, Vigilance, Product Field Actions/FSCA, recalls and Commercial Holds within the medical-device environment.

• Strong project, time and priority management skills, with the ability to independently manage multiple parallel PMS activities and deadlines.

• Resilient and comfortable working in an environment with changing priorities, urgent activities and competing deadlines.

• Strong problem-solving skills and ability to exercise sound judgement when dealing with incomplete or changing information.

• Demonstrates ownership and drives assigned activities from initiation through follow-up and completion with minimal supervision.

• Strong coordination and stakeholder-management skills with the ability to work effectively across functions, countries, divisions and organizational levels.

• Clearly and confidently communicates regulatory and quality requirements to internal and external stakeholders.

• Proactively follows up on outstanding information and actions and appropriately escalates delays, unclear responsibilities or compliance risks.

• Ability to create structure and direction in complex situations involving multiple stakeholders and changing priorities.

• Ability to review and interpret product, complaint, distribution and quality information and translate requirements into practical execution activities.

• Communicates and advises other departments and business units on post-market surveillance requirements and processes.

• Engages with Competent Authorities and other key stakeholders on routine and more complex matters with appropriate support.

• Supports preparation of briefings, regulatory correspondence and other PMS documentation.

• High attention to detail, process consciousness and strong documentation skills.

• Ability to identify process inefficiencies and actively contribute to continuous improvement and standardization.

• Strong interpersonal skills and ability to build effective working relationships within a complex matrix organization.

• Strong IT skills, including Microsoft Office; experience with quality systems such as TrackWise and reporting tools is advantageous.

• Fluent in German and English; additional languages are beneficial.

Germany Pay Ranges:

• Freiburg/Stetten 35Std: €4.211 - €7.049 EUR Monthly
• Schonkirchen/Kiel 35Std: €4.562 - €7.637 EUR Monthly
• Freiburg/Stetten 39Std: €4.692 - €7.855 EUR Monthly
• Tuttlingen 40Std: €4.813 - €8.056 EUR Monthly
• Berlin/Duisburg/Waghäusel/field-based 40Std: €63.000 - €104.900 EUR Annual

At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.