We are reinventing drug delivery across the continuum of care with connected, software-based solutions from the hospital to the home. We focus on creating user-friendly, innovating patient- centered care and safe solutions; were looking for an excellent and experienced Regulatory Affairs Engineer to join our great team. You will join a dynamic and fast-paced environment and work with a team of talents to build and roll-out cutting-edge products that deliver the companys innovative vision and strategy.
Job Description:
You will Support the process of adverse events reporting to various countries worldwide You will Communicate with worldwide authorities.
As a Regulatory Affairs Engineer you will Conduct RA strategy and evaluation of: (i) design changes, (ii) Materials non conformities and (iii) investigations Field action/Recalls execution Leading Post Market Surveillance activities Participating and supporting in additional cross-department tasks.
Direct manager: Regulatory Affairs Director.
Job Description:
You will Support the process of adverse events reporting to various countries worldwide You will Communicate with worldwide authorities.
As a Regulatory Affairs Engineer you will Conduct RA strategy and evaluation of: (i) design changes, (ii) Materials non conformities and (iii) investigations Field action/Recalls execution Leading Post Market Surveillance activities Participating and supporting in additional cross-department tasks.
Direct manager: Regulatory Affairs Director.
Requirements:
Experience:
Minimum of 1 year experience as a quality/regulatory specialist.
Education:
Bachelor’s degree in a scientific discipline or equivalent.
Language skills:
English – Mother tongue level.
Computer skills: full control in Office, SAP – advantage.
Other:
o Availability for intensive work, including unconventional hours when required.
o Ability to work under pressure and in tight schedules.
o Strategic thinking from planning to execution and follow up for regulatory and quality.
Experience:
Minimum of 1 year experience as a quality/regulatory specialist.
Education:
Bachelor’s degree in a scientific discipline or equivalent.
Language skills:
English – Mother tongue level.
Computer skills: full control in Office, SAP – advantage.
Other:
o Availability for intensive work, including unconventional hours when required.
o Ability to work under pressure and in tight schedules.
o Strategic thinking from planning to execution and follow up for regulatory and quality.
This position is open to all candidates.
