Regulatory & Scientific Affairs Specialist

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 list the applicable regulatory standards that the functions involved translates 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 UpToDate 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 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 etc. (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 techniquesProject 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!