Life Sciences | Regulatory Affairs Officer – Medical Devices Lisboa

Life Sciences | Regulatory Affairs Officer – Medical Devices
Lisboa
Lisboa, Lisboa, Portugal

ALTEN Portugal, a leading consultancy in Engineering, IT, and Life Sciences, is looking for a Regulatory Affairs Officer to support projects in the Medical Devices sector. We are seeking candidates with 1 to 3 years of relevant experience and a passion for regulatory compliance and innovation.

ALTEN Group

Within 30 years, ALTEN has become leader in both outsourced Engineering and IT Enterprise Services. ALTEN, composed of 54, 000 employees (88% engineers), carries out complex and highly technical projects throughout the value chain of 6, 500 clients, the most prestigious companies in all sectors of industry, services and telecommunications. We work with key actors in the Aeronautics & Space, Defense & Naval, Security, Automotive, Rail, Energy, Life Sciences, Finance, Retail, Telecommunications and Services sectors.

Do you want to work in exciting projects at renowned clients? At ALTEN we believe that knowing and meeting the expectations of our consultants is a key factor in our success. Our consultants make the difference. Do you want to make the difference too?

As a Regulatory Affairs Officer , you will play a critical role in ensuring medical device products comply with national and international regulatory frameworks throughout their lifecycle.

Key Responsibilities:

• Assist in the preparation, submission, and
  - up of regulatory dossiers and technical documentation.
• Ensure compliance with MDR (Medical Device Regulation) and other applicable standards.
• Review and maintain technical files, Instructions for Use (IFUs), labelling, and packaging materials.
• Monitor regulatory changes and assess their impact on products and documentation.
• Collaborate with Quality, R&D, Marketing, and Manufacturing teams to maintain ongoing compliance.
• Support internal audits and address requests from regulatory authorities when needed.

Qualifications:

• Degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field.
• 1–3 years of experience in Regulatory Affairs , ideally within Medical Devices .
• Solid understanding of MDR and related standards (e. g. , ISO 13485, MDSAP).
• Fluent in English (mandatory); other languages are a plus.
• Detail-oriented,
  - organized, and comfortable working independently and
  - functionally.

Location: Hybrid (Lisbon)

Why Join Us?

• Possibility to work with
  - edge technology in the Life Sciences industry
• Collaborative and dynamic work environment
• Possibility to join a
  - leading company in the industry
• Continuous trainings
• Possibility to join different and interesting projects

If you want to embrace in a new and challenging opportunity and are excited about the opportunity to contribute to our team, we want to hear from you! Please submit your resume and cover letter detailing your relevant experience and qualifications.