Regulatory Affairs Specialist in Software as a Medical Device (100% remote from Portugal or Spain))

We are looking for a "Regulatory Affaris Specialist" for one of our clients in the Pharmaceutical Sector.

SKILLS 🤹:

• Bachelor's/Master's degrees or equivalent experience:

Scientific studies in biology, biochemistry, or analytical chemistry. "Equivalent Experience" may include completion of training as a technician, laboratory technician, or a comparable qualification, combined with several years of relevant professional experience

• Experience:
  • Professional experience in the field of laboratory diagnostics (R&D, clinical trials, quality control) or in regulatory affairs or quality management.
  • Professional experience in Regulatory, R&D, Quality, Operations, and/or Clinical Operations. Capable of managing moderately complex projects
  • Good understanding of healthcare regulatory frameworks
  • Basic understanding and application of regulatory strategy
  • IT skills: Proficient in MS Office, databases, and document management systems
  • Language skills: Good English skills (fluent in spoken and written English)

TASKS & RESPONSIBILITIES 🚀:

     1. Regulatory Document and Submission Compilation

Leads the preparation and management of regulatory dossiers and comprehensive global submission plans for moderately complex products or programs.

2. Teamwork and Communication

Builds strong collaborative relationships, actively contributes to team efforts, communicates clearly and openly, listens effectively, and supports knowledge sharing and conflict resolution.

3. External Interface Management
Proactively partners with stakeholders to identify needs and solutions, builds strategic external relationships that influence Roche’s direction, and supports audits.

4. Regulatory Knowledge and Strategy
Develops solid understanding of healthcare regulatory frameworks (e.g., IVDR) and uses this knowledge to design regulatory strategies for products of simple to moderate complexity.

5. Stakeholder Management and Influencing
Effectively identifies and manages stakeholder relationships, ensuring timely and impactful communication to build trust and long-term collaboration.

6. Decision Making
Independently addresses daily tasks, identifies issues and solutions, and practices sound decision-making by gathering information, analyzing options, and acting without delay.

7. Innovation and Problem Solving
Drives innovation by generating new ideas, resolving issues collaboratively, and offering viable solutions while leveraging diverse perspectives.

8. VAAC Leadership and Agility
Embraces inclusive leadership, shows initiative, adapts to change, and demonstrates integrity, courage, and agility in identifying opportunities and contributing to team growth.

SCHEDULE 🕘:

• 08/09h -17/18h from Monday to Friday (flexible)
• 100% remote position
• Some business travel may be required

CONDITIONS 🌱:

• Salary package based on your profile. 
• Permanent Contract.
• Learning & Development.

Our goal is that you are well in every way!