Regulatory & Scientific Affairs Specialist

Stevanato Group; Liguria; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A growing healthcare organization in Italy is seeking a Regulatory & Scientific Affairs Specialist. The successful candidate will oversee the regulatory intelligence process and manage submissions to international regulatory agencies. Candidates should have 2-5 years of experience in the pharmaceutical or medical device industries, along with a Technical Master Degree and knowledge of applicable standards. This role offers the opportunity to work in a dynamic team environment where people are valued and empowered.

Competenze

• 2-5 years of experience in quality healthcare industries.
• Familiarity with FDA and Medical Device Regulations.
• Understanding of Quality Management Systems.

Mansioni

• Execute Regulatory Affairs strategy and provide feedback.
• Monitor regulatory requirements and assess relevant risks.
• Prepare necessary documents for regulatory approvals.
• Maintain accurate and up-to-date regulatory files.
• Collaborate with Compliance team and participate in audits.
• Monitor global regulations and participate in seminars.

Conoscenze

Experience with regulatory processes

Knowledge of ISO standards

Risk Management methodologies

Project Management skills

Formazione

Technical Master Degree

Descrizione del lavoro

We are looking for a Regulatory & Scientific Affairs Specialist to join our team in Italia (Piombino Dese). The chosen candidate will be responsible for or performing the regulatory intelligence process and regulatory and standard assessments, arranging registration dossier of medical devices, drug device combinations and drug container systems as well as participating in the dossier submission to the International Regulatory Agencies.

Key Responsibilities

• Executes the approved Regulatory Affairs strategy plan, providing the manager above with feedback and insights aimed at addressing the decision‑making process and implementing continuous improvements actions and initiatives.
• Participates in monitoring the regulatory requirements, assesses the relevant risks and impacts, and lists the applicable regulatory standards that the functions involved translate into procedures.
• Prepares required documents (such as LoA, Technical documents and declarations) for the approval of the manager above and for response to relevant stakeholders such as Regulatory Agencies, Bodies, Health Authorities.
• Maintains timely, accurate, exhaustive and up‑to‑date all regulatory files, ensuring the accuracy and alignment with applicable standards, norms and regulatory requirements, applying guidelines, procedures and approach to functions involved.
• Collaborate with Compliance team on reviewing procedures, work instructions, and other relevant documents, ensuring the alignment of all SG plants and their compliance with Quality Management System and applicable standards.
• Monitors and assesses impact of relevant global regulations, guidelines, and current regulatory environment by collecting information retrieved from scientific journals, institutional and academic websites, guidelines, databases and from the participation of seminars and symposiums.
• Participates, collaborating with the team and the manager above’s services in the audit sessions as well as during the customers' technical meetings, defining appropriate CAPA plan, working closely with the involved teams, able at solving the relevant findings, ensuring sustainable and long‑term efficacy and efficiency at both processes and systems level.

Qualifications

• 2-5 years of experience within quality healthcare (Pharmaceutical, Medical Device, Pharmaceutical Packaging) industries
• Technical Master Degree
• Knowledge of Regulatory, Legal and standard requirements applicable
• Knowledge of applicable standards such as ISO, cGMPs, FDA, Medical Device Regulations (such as ISO 13485, 14971, MDR etc.)
• Knowledge of Risk Management: methodologies, techniques, tools and applications (i.e., FMEA, control strategy)
• Knowledge of Quality Management System: process, features techniques, Project Management: methodologies, techniques, tools and applications

About Us

We are a dynamic organization with great customers and a culture where people are valued and empowered to deliver amazing results. We are also growing and looking to hire talented and passionate individuals to join our team!