Regulatory & Quality Affairs Specialist

NOVAX PHARMA; Italia; In loco; EUR 60.000 - 80.000; Tempo pieno

Descrizione del lavoro

A pharmaceutical manufacturing company is seeking a Regulatory & Quality Affairs Specialist based in Monaco. The ideal candidate has over 5 years of experience in regulatory affairs, strong knowledge of MDR and ISO 13485, and is fluent in English. The role involves developing regulatory strategies, overseeing quality management systems, and supporting cross-functional teams. This position requires onsite presence with no relocation package offered.

Competenze

• 5+ years of experience in Regulatory Affairs and Quality Assurance.
• Solid knowledge of MDR, ISO 13485, and EU regulatory frameworks.
• Ability to work cross-functionally and manage multiple projects.

Mansioni

• Develop and implement regulatory strategies; prepare documentation for Health Authorities.
• Act as the point of contact for regulatory authorities.
• Oversee quality management systems and supplier compliance.

Conoscenze

Regulatory Affairs

Quality Assurance

Project Management

Analytical Skills

Communication Skills

Fluent English (B2)

Knowledge of MDR and ISO 13485

Formazione

Degree in Life Sciences, Pharmacy, Engineering

Bachelor's, Master's, or PhD in biological sciences

Descrizione del lavoro

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

[e-mail]

[e-mail]

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Legal

Industries

• Pharmaceutical Manufacturing

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