Manager Clinical Development (m/f/d)

Date: Jun 15, 2022

Location: Wehrheim, HE, DE, 61273

Company: Heraeus

[title]
Manager Clinical Development (m/f/d)
Location Wehrheim
Permanent 
Full Time
 

Imagine a job where you will have the opportunity to do exciting and challenging work while collaborating with extraordinary colleagues. A company that invests in you and your career, providing the training, mentoring, development, and support you need to be successful now and in the future. If you want a career without limits with a market-leading, family-owned, global company where you can make an impact, then imagine an opportunity at Heraeus. Every day, our worldwide team of around 16,200 employees brings forward new ideas and solutions that are impacting and transforming everything from healthcare and renewable energy to e-mobility, high-tech, and telecommunications.

 
 

The following challenges await you:

  • Thanks to you, patients will continue to benefit from our successful products. 
  • As a clinical product specialist, you prepare the clinical and scientific documentation (e.g., CEP, CER, PMS & PMCF plan, SSCP) as part of the clinical evaluation for the initial approval or the maintenance of the approval as required by MDD and MDR.
  • You competently answer the clinical questions raised by competent authorities and the notified body.
  • You evaluate clinical content in marketing materials and develop product-specific PMS and PMCF activities in cooperation with marketing. 
  • As part of cross-functional teams for novel products or line extensions, you are responsible for the timely consideration of clinical topics during the development process and always keep an eye on the approval requirements. 
  • You create and update the clinical development plan and synopses for clinical investigations.
  • Together with your colleagues in the Clinical Development Team, you are the person to contact in the company for all clinical science questions regarding the products.

 

Your profile:

  • Degree in the field of life sciences, preferably PhD or equivalent
  • At least 3 years of experience in clinical research or development of medical devices, biotechnology, or pharmaceutical industry on an international level
  • Know-how about the clinical documentation required for medical devices, e.g., Clinical Evaluation Plan, Clinical Evaluation Report, PMS & PMCF Plan, SSCP
  • Knowledge of relevant laws and guidelines, e.g., MDD/MDR, FDA/510k, ICH-GCP
  • Ideally experience in orthopaedics or the development of (antibiotic-containing) combination products
  • Fluent in German and English, additional language skills welcome
  • Strong team player with organizational skills and a positive attitude, dedication and just as much analytical as intercultural competence