Regulatory & Quality Affairs Specialist

Overview

We are seeking a Regulatory & Quality Affairs Specialist to join our team and support the development, compliance, and quality of our innovative products. This role bridges regulatory strategy, quality assurance, and cross-functional collaboration to ensure our products meet the highest standards. The role is based in Monaco and requires onsite presence / commuting to the offices in Monaco.

Responsibilities

• Develop and implement regulatory strategies; prepare and submit documentation to Health Authorities and Notified Bodies (MDR, ISO 13485, EU/Non-EU regulations).
• Act as the point of contact for regulatory authorities on vigilance and compliance matters.
• Oversee quality management systems, supplier compliance, and internal/external audits.
• Review and approve packaging documentation and ensure compliance of packaging claims and EU compliance.
• Support cross-functional teams (R&D, Marketing, Procurement, Legal) on regulatory and quality topics.
• Monitor evolving global regulations and propose action plans to maintain compliance.
• Contribute to innovation projects, training programs, and continuous improvement initiatives.

Qualifications

• Degree in Life Sciences, Pharmacy, Engineering, or related field.
• Proven experience in Regulatory Affairs and Quality Assurance within the medical device, pharmaceutical, or related industry.
• Solid knowledge of MDR, ISO 13485, and EU/Non-EU regulatory frameworks.
• Strong organizational, analytical, and communication skills.
• Ability to work cross-functionally and manage multiple projects.
• Bachelor’s degree or Master’s or PhD degree in biological sciences, biotechnology, pharmacology, chemistry.
• Good working knowledge of the MDD/MDR, ISO standards.
• Previous work experience in the pharma or medical field/ medical device field.
• At least 5+ years experience with regulatory affairs.
• English Fluently (B2) is a requirement. Italian is an asset.
• Experience with medical device and/or pharma.
• Preference for candidates already located in Monaco, surrounding countries, and Europe.
• Please note that there is no relocation package.

Contacts

info@novaxpharma.com

contactdp@novaxpharma.com

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Legal

Industries

• Pharmaceutical Manufacturing

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