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.
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.