Regulatory Affairs Specialist / Manager (m/f/d)

SCIRENT Clinical Research and Science; Berlin; Vor Ort; EUR 70.000 - 100.000; Vollzeit

Benefits dieser Stelle

Company pension

Welcome trips

In-house training

International team

Central Berlin office

Zusammenfassung

SCIRENT Clinical Research and Science in Berlin is seeking a Regulatory Affairs Specialist/Manager (m/f/d) with at least two years of experience in EU regulatory affairs. The role focuses on EU clinical trials, CTIS/CTA submissions, and EU MDR for medical devices.

You will prepare regulatory submissions, liaise with authorities, ethics committees, study sites and clients, and maintain regulatory documentation while supporting a fast-paced, international team in a modern Berlin office.

Qualifikationen

• At least 2 years of professional experience in Regulatory Affairs.
• Experience with EU regulatory processes.
• Experience with CTIS/CTA is an advantage.
• Experience with EU MDR/Medical Devices is an advantage.
• Professional working proficiency in English.
• German language skills are an advantage.
• Structured, independent and reliable way of working.
• Strong organizational and communication skills.
• Willingness to work regularly from our Berlin office.

Aufgaben

• Support and manage regulatory activities for clinical trials in the EU
• Prepare and coordinate regulatory submissions
• Support CTIS/CTA submissions and related activities
• Support regulatory activities for medical devices under EU MDR
• Prepare, review and maintain regulatory documentation
• Communicate with regulatory authorities, ethics committees, study sites and clients
• Track regulatory requirements, submissions and timelines

Kenntnisse

Regulatory affairs

English proficiency

German language

Organizational skills

Communication skills

Jobbeschreibung

SCIRENT Clinical Research and Science is seeking a Regulatory Affairs Specialist / Manager (m/f/d) to join our team in Berlin. We are looking for an experienced Regulatory Affairs professional with at least two years of professional experience in EU Regulatory Affairs. Experience with CTIS/CTA and/or EU MDR/Medical Devices would be an advantage.

SCIRENT was founded in 2012 with the vision of helping customers develop innovative medical drugs and devices for patients with cardiovascular diseases. Our dedicated team of experienced clinical and regulatory professionals share their enthusiasm for developing effective therapies for cardiac patients. What sets us apart from our competitors is our profound expertise in cardiovascular therapy and diagnostics. Our CRO offers access to an impeccable network of dedicated trial centers in Europe and North America with extensive experience in cardiovascular studies. Our customers appreciate our lean and agile management, which generally makes our performance faster and more efficient.

Your responsibilities

• Support and manage regulatory activities for clinical trials in the EU
• Prepare and coordinate regulatory submissions
• Support CTIS/CTA submissions and related activities
• Support regulatory activities for medical devices under EU MDR
• Prepare, review and maintain regulatory documentation
• Communicate with regulatory authorities, ethics committees, study sites and clients
• Track regulatory requirements, submissions and timelines

Your profile

• At least 2 years of professional experience in Regulatory Affairs
• Experience with EU regulatory processes
• Experience with CTIS/CTA is an advantage
• Experience with EU MDR/Medical Devices is an advantage
• Professional working proficiency in English
• German language skills are an advantage
• Structured, independent and reliable way of working
• Strong organizational and communication skills
• Willingness to work regularly from our Berlin office

What We Offer

• Compensation: Attractive salary and a company pension scheme.
• Onboarding: Welcome trips to our partner countries and a newcomers meet & greet.
• Training and Development: In-house training in clinical research, voluntary language courses and regular coaching sessions.
• Work Environment: International working environment with access to our offices across Europe. Laptop and phone are provided.
• Location: Modern office in central Berlin with good public transport connections.