Responsabile affari regolamentari

Job Title: Regulatory Affairs Manager

Location: Monsano (AN)

Departments: Technical Area & Regulatory Affairs

About Us:

Chema Diagnostica is a SME in the diagnostic medical device industry, committed to providing high-quality solutions for improving patient care worldwide. We specialize in In Vitro Diagnostic medical devices (IVD) and we are dedicated in maintaining compliance with standards and regulations to ensure the safety and performance of our devices.

Job Overview:

We are seeking a highly motivated Regulatory Affairs Manager to join our team in Chema Diagnostica.

As a key role you will require strong leadership, organizational, and multitasking skills to join our Technical Area & Regulatory Affairs Department. You will coordinate and manage multiple projects simultaneously, while also leading the Technical Area, which includes the Regulatory Affairs, Quality Control, and R&D departments. The role requires close collaboration with the Quality Assurance (QA) department, ensuring alignment of regulatory, technical, and quality strategies.

The Regulatory Affairs Manager will play a key role in driving the company’s IVDR transition process, ensuring that the entire product portfolio achieves full compliance with IVDR requirements through complete technical documentation (TD).

Key Responsibilities:

Regulatory & Operational Activities

• Oversee regulatory submissions and interactions with authorities, ensuring compliance with IVDR, ISO 13485, and ISO 9001.
• Lead and coordinate product registration and certification processes with clients and competent authorities.
• Develop, review, and maintain regulatory technical documentation (TD) for the company's IVD portfolio.
• Manage Post-Market Surveillance and Vigilance processes, interacting where necessary with European and International Regulatory Authorities to comply with legal obligations.
• Participate in various company product improvement or new product development projects, providing guidance on the tests to be performed to ensure device compliance with applicable regulatory requirements.
• Provide support to R&D departments in planning and conducting stability studies, product validation, and device performance verification.
• Monitor changes in international and European regulatory frameworks and assess their impact on company operations.
• Support audits, inspections, and conformity assessments, providing regulatory expertise during external and internal reviews.
• Ensure effective communication and collaboration with QA to align regulatory, quality, and compliance requirements.

Managerial, Leadership & Strategic Activities

• Manage and coordinate the Technical Area, supervising the RA, QC, and R&D teams.
• Provide leadership, mentorship, and professional development opportunities to team members.
• Define and implement the company's regulatory strategy in line with business objectives.
• Prioritise and allocate resources across multiple ongoing projects, ensuring timely delivery and compliance.
• Act as a key advisor to senior management on regulatory risks, opportunities, and strategic decisions.
• Foster cross-functional collaboration to drive innovation, efficiency, and continuous improvement.
• Represent the company in interactions with external stakeholders, including regulatory bodies, notified bodies, and industry associations.

Qualifications/Skills:

• Degree in Pharmacy, Biology, Biotechnology, Life Sciences or a degree in a related field.
• 1 or 2 years' experience in a similar role with expertise and experience in IVDR
• and ISO 13485:2016.
• Risk based approach in compliance with ISO 14971:2022.
• Clinical and Analytical Chemistry skills.
• Strong attention to detail, problem-solving skills, and ability to work independently.
• Ability to prioritize and manage multiple tasks in a fast-paced environment.
• Strong leadership, strategic and critical thinking.
• Ability to meet deadlines while complying with regulatory constraints.
• Excellent communication skills, both written and spoken.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
• Good knowledge of English language both written and spoken.

Contract type and period:

On-site permanent contract.

How to Apply:

Please submit your resume and cover letter to