Senior Regulatory Affairs Project & PMS Manager - Clinical Business (m/w/d)

Stellenbeschreibung

Headquartered in Tokyo, Japan, Evident employs around 4,500 people at a total of 57 locations worldwide. Evident Europe, headquartered in Hamburg, Germany, employs approximately 770 people in 16 countries. The product portfolio includes a wide range of microscope systems used in clinical diagnostics, medical and basic research, as well as in various industrial areas. In addition, Evident offers videoscopes, products for non-destructive testing techniques and for X-ray fluorescence analysis.

The Senior Regulatory Affairs Project & PMS Manager (m/f/d) will lead regulatory planning and execution for IVD and medical devices throughout new product development and post-market phases. This role ensures global regulatory compliance, creates and implements regulatory strategies, and maintains technical documentation and submissions for international markets. The position also acts as the key contact with global health authorities, securing market access for innovative products.

Tasks

• Regulatory Strategy and Planning: Develop and execute regulatory plans, provide guidance, and conduct impact assessments.
• Technical Documentation: Create and maintain technical documentation, collaborating with R&D, Quality, and Clinical teams.
• Global Submissions: Prepare and manage registration dossiers, coordinate filings, and monitor regulatory updates.
• Regulatory Interactions: Act as the primary contact for regulatory meetings and communications.
• Project Management: Manage regulatory deliverables, coordinate teams, and ensure alignment with project plans.
• PMS Management: Develop and maintain PMS systems, design and execute plans, and oversee regulatory documents.
• Adverse Event Reporting: Manage investigations and reporting of adverse events, lead root cause analysis, and maintain records.
• Data Analysis: Analyze PMS data, collaborate on evaluations, and ensure alignment with the QMS.
• Global Compliance: Monitor global PMS requirements, provide guidance, and support audits and submissions.

Requirements

• Education: Bachelor's degree in life sciences, biomedical engineering, regulatory affairs, or related field. Certification in regulatory affairs or project management is a plus.
• Experience: 7-10 years in regulatory affairs for IVD or medical devices, with experience in NPD and global submissions. Proven track record in regulatory submissions and interactions with authorities.
• Skills: Understanding of global regulatory frameworks, project management, analytical and problem-solving skills, strong communication, collaborative mindset, proficiency in PMS tools, and knowledge of risk management principles.

Benefits

• Flexible working hours, 50% remote work possible
• 30 days of holiday per year
• 13,5 salaries a year
• Modern office and inspiring working environment
• Subsidized meals in the neighborhood of our office (Stadtküche)
• Public transport ticket (100% subsidized) or free parking space
• Bike leasing
• Subsidy fitness first gym
• Employee Assistance Program to support your health, mental and emotional well-being
• Comprehensive company pension scheme
• Joint company events and activities

Evident Europe GmbH is an equal opportunities employer and we look forward to receiving your application.

Kontakt

EVIDENT Europe GmbH