Safety and Reporting Senior Specialist – Post Market Quality

As a Safety and Reporting Senior Specialist of Post Market Quality, you will be a key player within our Quality and Regulatory organization. Working with a high degree of autonomy and minimal supervision, you will ensure our products maintain the highest standards of safety and compliance after they reach the market. You will dive into complex cases, collaborate globally, and contribute to continuous improvement in a dynamic, patient‑centric environment. Responsibilities

Case & Report Management:

Take accountability for the timely and compliant handling of safety, vigilance, and Post‑Market Surveillance (PMS) cases/reports, strictly adhering to ISO Quality System requirements and country‑specific regulations. Regulatory & Affiliate Collaboration:

Interface directly with Regulatory Authorities (e.g., FDA, Notified Bodies) and Affiliate Organizations. Coordinate, prepare, and deliver precise responses by collaborating with integral subject matter experts. Post‑Market Surveillance (PMS):

Maintain and facilitate the schedule of PMS reports, drive data generation, and lead the planning, completion, and evaluation of PMS activities for various product families. Quality System & Process Improvement:

Develop advanced monitoring systems for data and PMS reports to boost efficiency. Review case quality and customer feedback to optimize our internal processes. Compliance & Risk Management:

Ensure all records meet established quality processes,



and take ownership of completing thorough risk assessments for product quality issues. Training, Mentoring & Squad Support:

Participate in developing and delivering training on vigilance/safety/PMS topics. Onboard and coach less experienced colleagues, lead or contribute to agile projects (e.g., SQUADs), and act as a proxy for the Principal Specialist when needed. Qualifications & Experience

Education

Bachelor’s degree in Sciences and/or vocational training with equivalent related experience. Experience:

3+ years of experience working in a regulated environment (preferred experience in Quality Systems, Vigilance, and/or Safety). Languages:

Fluent professional knowledge of English is required. Knowledge of German is a strong asset. Technical Savvy:

Laboratory experience and/or strong IT skills are highly preferred. Global Mindset:

Proven experience working successfully in virtual, cross‑functional, and intercultural teams. Leadership & Soft Skills:

Critical Thinking & Problem Solving: Ability to make sound decisions even when dealing with limited or ambiguous information. Resilience & Confident Manner: A strong sense of quality, a solution‑oriented mindset, and the ability to adapt to changing environments. Communication & Technical Writing: Excellent negotiation skills and the ability to author technical documentation tailored for regulatory authorities. Roche is an Equal Opportunity Employer.

📌 Safety and Reporting Senior Specialist of Post Market Quality (Madrid)
🏢 F. Hoffmann-La Roche
📍 Madrid