Product & Regulatory Compliance Specialist

PRAMAC; Siena; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

PRAMAC is seeking a Product & Regulatory Compliance Specialist to join our HQ team in Casole d'Elsa, Italy. You will support development, certification, and market access for our products worldwide, working with Engineering, R&D, Quality, and external certification bodies.

Responsibilities include managing CE marking, conformity assessment for machinery and electrical equipment, maintaining technical files, and monitoring regulatory changes across Europe and beyond. Fluent English required.

Qualifications

• Degree in Engineering or a scientific/technical field.
• 2-3 years of experience in Product Compliance, Regulatory Affairs, Product Certification, Quality Engineering or related functions.
• Good knowledge of European product regulations and conformity assessment processes.
• Experience with CE marking and directives for industrial products.

Responsabilités

• Manage product compliance activities across Pramac's product portfolio, ensuring conformity with applicable European and international regulations.
• Coordinate CE marking processes and conformity assessment for machinery, electrical equipment, battery systems and other industrial products.
• Prepare, review and maintain technical documentation, technical files, declarations of conformity, certificates and compliance records.
• Interpret and monitor regulatory frameworks, standards and legislative developments affecting products and processes.
• Support new product development by providing regulatory guidance during design, validation and certification phases.
• Collaborate with cross-functional teams to ensure compliance requirements are implemented.

Connaissances

Regulatory Affairs

Product Compliance

CE marking

Regulatory standards

Stakeholder management

Analytical thinking

Fluent English

Formation

Engineering degree

Outils

Regulatory databases

Description du poste

We are looking for a Product & Regulatory Compliance Specialist to join our HQ team and support the development, certification, and market access of our products worldwide.

Working closely with Engineering, R&D, Quality, Supply Chain, Procurement, Product Management and external certification bodies, the successful candidate will ensure compliance with applicable regulatory requirements and international standards throughout the product lifecycle.

Key Responsibilities

• Manage product compliance activities across Pramac's product portfolio, ensuring conformity with applicable European and international regulations.
• Coordinate CE marking processes and conformity assessment activities for machinery, electrical equipment, battery systems and other industrial products.
• Prepare, review and maintain technical documentation, technical files, declarations of conformity, certificates and compliance records.
• Interpret and monitor applicable regulatory frameworks, standards and legislative developments, assessing their impact on products and business processes.
• Support new product development projects by providing regulatory guidance during design, validation and certification phases.
• Collaborate with Engineering, Quality, Procurement, Supply Chain and Product Management teams to ensure compliance requirements are properly implemented.
• Manage supplier compliance documentation related to REACH, RoHS, Battery Regulation and other material compliance requirements.
• Support environmental compliance activities, including WEEE, recycling obligations and end-of-life product requirements.
• Participate in certification projects with external laboratories, notified bodies and regulatory authorities.
• Maintain compliance databases, regulatory registers and reporting tools.
• Contribute to initiatives related to sustainability, battery passport, product traceability and digital product information requirements.
• Support internal and external audits and ensure proper management of compliance documentation.
• Deliver compliance-related training and awareness activities to internal stakeholders when required.

Requirements & Skills

• Degree in Engineering or a scientific/technical field.
• 2-3 years of experience in Product Compliance, Regulatory Affairs, Product Certification, Quality Engineering or related technical functions within an industrial environment.
• Good knowledge of European product regulations and conformity assessment processes.
• Familiarity with CE marking requirements and applicable directives/regulations for industrial products.
• Knowledge of REACH, RoHS, Battery Regulation, WEEE or similar regulatory frameworks is considered a strong plus.
• Experience interacting with certification bodies, testing laboratories and external auditors.
• Fluent English, both written and spoken.
• Strong analytical and problem-solving skills.
• Excellent attention to detail and organizational capabilities.
• Ability to manage multiple activities and deadlines in a dynamic international environment.
• Effective communication and stakeholder management skills.
• Proactive attitude and continuous improvement mindset.

Preferred Qualifications

• Experience in sectors such as power generation, energy storage, batteries, electrical equipment, machinery, automotive or industrial manufacturing.
• Experience working within international and matrix organizations.
• Knowledge of ISO standards and quality management systems.

Work Location

Casole d'Elsa (SI), Italy