Regulatory Affairs Professional - Maternity Leave (m/f/d) Porto

Regulatory Affairs Professional - Maternity Leave (m/f/d)
Porto
Porto, Porto District, Portugal

Quality Management & Regulatory Affairs Professional

Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the
- evolving healthcare industry.

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone to grow personally and professionally. Sound interesting?

Then come and join our team as QM&RA Professional!

Responsibilities:

1. Provide support to the Quality Department on QM/RA topics, in order to maintain certification processes and regulatory compliance.
2. Ensure compliance with all regulatory processes, in readiness for both internal and external audits.
3. Contribute to the regulatory activities performed, including
   - market notifications and
   - market surveillance activities.
4. Document and track regulatory submissions and regulatory authority requests/approvals.
5. General regulatory administration duties and compliance requirements.
6. Suggest areas for improvement with a focus on operational excellence.
7. Participate in a
   - country environment, interacting with Global and Southern Europe teams, sharing best practices and experiences.

About you:

1. Degree/Master's in Life Sciences, ideally a Pharmacy Degree.
2. Fluency in English and Portuguese.
3. At least 1 year of experience in RA in a Medical Device Company.
4. Knowledge of Quality Management, ISO standards, and medical device regulations.
5. A digital mindset and a keen interest in new healthcare technologies.
6. Structured way of thinking with an eye for details and critical thinking.
7. Hands-on mentality, independence, strong analysis and documentation skills, good teamwork in a
   - functional environment.
8. Good communication skills, learning seeker, team worker, initiative.

The employment is temporary (12 months). This job requires attendance at office and remote work.

Interested? Apply!!

Our global team:

We are a team of 66, 000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from
- vitro and
- vivo diagnostics to
- guided therapy and innovative cancer care, is crucial for clinical
- making and treatment pathways.

Our culture:

We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.