Clinical & Regulatory Affairs Specialist

vor 20 Stunden

Berlin, Deutschland Meditrial Europe Ltd. Vollzeit

**Company Overview**:
Meditrial is a dynamic and rapidly growing multinational company specializing in providing clinical and regulatory services to medical device companies in the USA and Europe. With a commitment to excellence and innovation, we empower our clients to navigate complex regulatory landscapes and bring life-changing medical devices to market efficiently and compliantly. Our dedicated team of experts ensures the highest quality standards and compliance with regulatory requirements.

**Clinical & Regulatory Affairs Specialist**:
**Industry**: Lifescience Industry: Pharma, Medtech, Digital Health

**Employment Type**: Full-time

**Job Functions**: Clinical/ Regulatory Affairs

**Location**: Meditrial,Kantstrasse 21, 10623, Berlin

**Workplace**: Office-based

**Responsibilities**:
Proactively manage project-level operations, including but not limited to, aspects including management of trial timeline, budget, resources with consideration of quality standards and risk mitigation
Provide efficient and effective updates on trial progress to the Medical Director as requested
Lead sponsor study start-up processes, including but not limited to, conduct of the trial kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements (CTAs) and budgets.
Ensure effective project plans are in place and operational for each trial. Proactively coordinate with the Clinical Trial Team to establish the priorities in accordance with applicable project plans, company standard operational procedures (SOPs), GCP guidelines and regulatory requirements.
Attend study update meetings, ensure meeting minutes are completed, distributed to team members and filed in the TMF in a timely manner. Review and approve site visit reports, ensure tracking, follow-up and resolution of site-specific issues have been completed in a timely manner.
Monitor the quality of deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team.

**Qualifications**:
Master’s degree in life science, healthcare management, preferred degrees include Medical Engineering, PharmD, MD, and/or PhD
**Language skills**: fluent English and German, Italian or French are considered a plus.
Previous experience in a pharmaceutical, CRO or medical device company required
Sound knowledge of GCP/CFR/ICH guidelines, ISO9001 and ISO14155

Personal skills
Over 5 + years of experience in clinical trial management medical device or drug
Ability to communicate, problem solve and work effectively in an international team
Innovative and self-motivated
Excellent organization skills and ability to prioritize goals and responsibilities
Ability to negotiate and communicate with clients in a professional manner

Proficient computer skills with the ability to understand and assess technology alternatives and implications for current processes
Ability to be productive and successful in a dynamic work environment

  • Regulatory Affairs Specialist

    Vor 6 Tagen

    Berlin, Berlin, Deutschland Terumo Europe, Middle East & Africa Vollzeit 50.000 € - 80.000 € pro Jahr

    At Terumo, we advance lifesaving medical technologies to benefit society. Are you eager to make a difference with us? Here, you'll grow your expertise while staying true to your personal aspirations.  Guided by our Japanese heritage, we act with respect, take ownership, and pursue continuous improvement. If you see yourself in our values, keep reading;...

  • Regulatory Affairs and Quality Specialist

    vor 18 Stunden

    Berlin, Deutschland BioTalent Vollzeit

    **Senior Quality Assurance & Regulatory Specialist**: **Introduction**: A spin-off of one of the world’s largest In-Vitro Diagnostics (IVD) manufacturers, located in Berlin is currently searching for an experienced Quality Assurance & Regulatory Affairs Specialist to join their ever growing team after a successful merger. **This role will offer you**: -...

  • Regulatory Affairs

    vor 1 Woche

    Berlin, Deutschland DeepSpin GmbH Vollzeit

    **Your mission**: **About DeepSpin** DeepSpin is a HealthTech startup pursuing the mission to make Magnetic Resonance Imaging universally accessible. Today 7 out of 10 people globally do not have access to this life-saving imaging modality. Through our cutting-edge technology we are going to change that. Backed by globally leading VCs, we are now expanding...

  • Manager, Regulatory Affairs

    vor 1 Woche

    Berlin, Deutschland Alimentiv Vollzeit

    Manager, Regulatory Affairs (Europe)Management of Regulatory Affairs personnel through line management and project delivery oversight. Responsible for developing study regulatory strategies and leading department initiatives. The role involves collaboration with other departments to support the successful approval of clinical trials. May have...

  • Quality and Regulatory Specialist

    vor 1 Woche

    Berlin, Berlin, Deutschland FormlyAI Vollzeit 60.000 € - 100.000 € pro Jahr

    Company DescriptionFormlyAI is changing the way the world achieves medical device compliance. Our team delivers quality and regulatory services to clients leveraging our expert team and intelligent, trusted AI solutions to ensure our clients get their life-saving technology to market and through regulatory certification faster than ever before. We are on the...

  • Studentische/n Mitarbeiter/in Regulatory Affairs

    vor 1 Woche

    Berlin, Deutschland Charité Healthcare Services GmbH Vollzeit

    **Sie haben Interesse an einer Mitarbeit in unserem Unternehmen?**: Dann bewerben Sie sich bitte auf eine unserer Stellenangebote oder initiativ. Ihre aussagekräftige Bewerbung sollte idealer Weise folgende Unterlagen enthalten: - Motivationsschreiben - Lebenslauf - ggf. relevante Zeugnisse und Zertifikate **studentische/n Mitarbeiter/in Regulatory...

  • Werkstudent Regulatory Affairs

    Vor 5 Tagen

    Berlin, Deutschland Charité Healthcare Services GmbH Vollzeit

    **Sie haben Interesse an einer Mitarbeit in unserem Unternehmen?**: Dann bewerben Sie sich bitte auf eine unserer Stellenangebote oder initiativ. Ihre aussagekräftige Bewerbung sollte idealer Weise folgende Unterlagen enthalten: - Motivationsschreiben - Lebenslauf - ggf. relevante Zeugnisse und Zertifikate **Werkstudent Regulatory Affairs (m/w/d)**: Die...

  • Senior Regulatory Affairs Specialist

    vor 2 Wochen

    Berlin, Deutschland Novanta Vollzeit

    Novanta is one global team with over 26 offices located in The Americas, Europe and Asia-Pacific. Looking for a great place to work? You have found it with a culture that embraces teamwork, collaboration and empowerment. Come explore Novanta. Primary Responsibilities Medical device approval: - Self-responsible compilation of registration-relevant...

  • International Regulatory Affairs Specialist

    Vor 3 Tagen

    Berlin, Deutschland Berlin-Chemie AG Vollzeit

    **Site**: Berlin**Specialist field**: Regulatory Affairs**Career level**: Experienced professionals**Commencement date**: with immediate effect**Type of contract**: Fixed-term**Working time**: Full-timeWithin our International Regulatory Affairs & Drug Safety Department in Berlin, you will be responsible for the acquisition and regulatory management of...

  • Head of Regulatory Affairs

    vor 1 Woche

    Berlin, Deutschland Tether Operations Limited Vollzeit

    Since its inception in 2014 by pioneering Bitcoin enthusiasts, Tether has not only launched the first 'stablecoin', USD₮, but also expanded its horizons into Tether Data, Tether Power, Tether Edu, and more. Our platforms and tokens lead in liquidity, stability, and innovation, setting the foundation for the future. Tether is committed to the...