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Helps. Cares. Protects.

Join our team as a

Senior Manager (f/m/d) Regulatory Affairs

DEU-Heidenheim

 

As part of the Regulatory Affairs team, we offer you an exciting and responsible role in a globally operating area. We enable our employees to get involved in interesting tasks in a modern working environment and to grow with them – personally and professionally. If you are as enthusiastic about our meaningful product portfolio as we are, we should get to know each other.
 
Your area of responsibility:    

 

  • In this role you act as a RA partner and point of contact for the Incontinence Management Business Division and coordinate the RA disciplines, e.g. clinical evaluation, post-marketing surveillance or labeling management
  • Enable compliance for the entire product portfolio of the Incontinence Management Business Division in all relevant markets
  • Accompanying development projects of product innovations and digitalization as well as advising on all RA issues
  • Participate in the writing and reviewing of Regulatory processes 
  • Ensure resources and activities are aligned with the Incontinence Management Business Division commercial objectives and plan RA activities accordingly
  • Carrying out the conformity assessment procedure for the technical documentation and declaration of conformity

 

What we look for:

 

  • Bachelor's or Master's degree in scientific, natural or technical sciences, or equivalent education
  • Very good regulatory affairs knowledge (MDD, MDR, etc.), optional knowledge of quality management is an advantage
  • Experience in project management and ideally in the management of international projects
  • Knowledge of business processes and global quality management systems in the medical device industry, such as ISO 13485
  • Interest to work in an international team
  • Fluent in English; ideally good knowledge of German

 

Benefits:

 

  • Well-developed infrastructure e.g. parking bays, canteen, well-equipped workspaces
  • Furnished apartment for the first six months, if distance to place of residence > 60 km
  • Flexible working conditions, e.g. flextime or mobile working on a daily basis
  • Feedback conversations and resulting training opportunities
  • Diverse development opportunities - national and international

 

Please send in your application documents via our online platform to Adele Frommholz.

Helps. Cares. Protects.

Join our team as a

Senior Manager (f/m/d) Regulatory Affairs

DEU-Heidenheim

 

As part of the Regulatory Affairs team, we offer you an exciting and responsible role in a globally operating area. We enable our employees to get involved in interesting tasks in a modern working environment and to grow with them – personally and professionally. If you are as enthusiastic about our meaningful product portfolio as we are, we should get to know each other.
 
Your area of responsibility:    

 

  • In this role you act as a RA partner and point of contact for the Incontinence Management Business Division and coordinate the RA disciplines, e.g. clinical evaluation, post-marketing surveillance or labeling management
  • Enable compliance for the entire product portfolio of the Incontinence Management Business Division in all relevant markets
  • Accompanying development projects of product innovations and digitalization as well as advising on all RA issues
  • Participate in the writing and reviewing of Regulatory processes 
  • Ensure resources and activities are aligned with the Incontinence Management Business Division commercial objectives and plan RA activities accordingly
  • Carrying out the conformity assessment procedure for the technical documentation and declaration of conformity

 

What we look for:

 

  • Bachelor's or Master's degree in scientific, natural or technical sciences, or equivalent education
  • Very good regulatory affairs knowledge (MDD, MDR, etc.), optional knowledge of quality management is an advantage
  • Experience in project management and ideally in the management of international projects
  • Knowledge of business processes and global quality management systems in the medical device industry, such as ISO 13485
  • Interest to work in an international team
  • Fluent in English; ideally good knowledge of German

 

Benefits:

 

  • Well-developed infrastructure e.g. parking bays, canteen, well-equipped workspaces
  • Furnished apartment for the first six months, if distance to place of residence > 60 km
  • Flexible working conditions, e.g. flextime or mobile working on a daily basis
  • Feedback conversations and resulting training opportunities
  • Diverse development opportunities - national and international

 

Please send in your application documents via our online platform to Adele Frommholz.