Job overview
For our Regulatory Unit, we are looking for a Regulatory Affairs Manager to handle the operational management of our clients' projects within the medical device and food supplement field. The ideal candidate has experience working with manufacturers of both medical devices and food supplements.

Main tasks and responsibilities:
The role will involve handling the following responsibilities:

• Preparing technical files for CE marking of medical devices in compliance with MDR 2017/745 and related guidance documents
• Developing and writing clinical evaluations for medical devices, including the creation of clinical evaluation plans (CEPs) and clinical evaluation reports (CERs)
• Creating post-market surveillance (PMS) and post-market clinical follow-up (PMCF) plans and reports for medical devices
• Defining the CE marking strategy for medical devices
• Defining the regulatory strategy for placing a food supplement on the market
• Tracking regulatory changes
• Interacting with regulatory authorities
• Conducting internal and external training activities

Minimum requirements:
Scientific Degree
At least 3 years of experience in regulatory affairs concerning medical devices and food supplements
Advanced level of English

Personal skills:
Attention to detail
Flexibility and adaptability
Initiative and proactivity
Teamwork orientation
Ability to organize work towards objectives
Strong communication skills

Line Manager: Biostatistics Coordinator

Main tasks and responsibilities:

• Contribute to the design of clinical trials by providing an appropriate statistical methodology
• Participate in the definition of study protocols, concept sheets and abstract
• Perform sample size calculation
• Prepare the Statistical Analysis Plan (SAP)
• Perform statistical analysis
• Review study objectives and endpoints with the team
• Prepare statistical reports and CSR statistical sections 
• Generate and manage randomization lists 

Minimum Requirements:

• At least 2 years of experience as Biostatistician (preferable in a CRO)
• Scientific degree in Statistics
• SAS programming
• Good English written and spoken

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Line Manager: Chief Operating Officer

Job overview
Responsible for setting up, coordinating and leading clinical studies and clinical investigations. Collaborates with the other clinical trial team members to oversee work within the various phases, monitors the study progress and provides regular updates to stakeholders, ensuring that the study is completed on time, adheres to budget constraints, and meets the required quality standards.

Main tasks and responsibilities are:

• Plan, initiate and manage clinical projects in accordance with all relevant guidelines, legislation and SOPs;
• Monitor the progress of the clinical trial against the project plan and performance indicators for quality and budget;
• Identify risks, and develop and implement plans to mitigate risks in collaboration with team members and other stakeholders;
• Act as a daily point of contact for the sponsor and members of the project team;
• Coordinate and supervise clinical research associate;
• Coordinate and supervise clinical vendors;
• Develop research-specific documents;
• Report progress to the internal team, the client and the stakeholders;
• Negotiate contracts with research centres and suppliers;
• Manage project finances in accordance with the sponsor contract and budget;
• Provide input for proposals and budgets, and in bid defence meetings;
• Perform training to the study team on company procedures and processes related to the clinical operations;
• Perform submission to the EC and CA.

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Main tasks and responsibilities (in cooperation with the Head of Quality Management):

• Maintain GCP/ICH and ISO 9001 compliant systems and processes which control the quality of work and clinical trials conducted 
• Write and/or review clinical SOPs and support continuous process improvements
• Manage training of staff on company procedures, GCP regulations, and documentation systems
• Manage induction training for new employees and for scientific consultants
• Qualify critical vendors
• Perform documentation control in the TMF and quality reviews of clinical trial essential documents and associated documentation (including Protocols, Investigator’s Brochure, CRFs, etc.) as appropriate
• Perform routine internal System and TMF audits and checks throughout the lifecycle of a trial/program to ensure compliance with internal procedures, as well as regulatory guidelines
• Report significant clinical quality deficiencies and/or risks to upper management and actively participate in solving the issues
• Perform clinical site GCP auditing activities to ensure that studies are conducted in accordance with protocols, GCP and other applicable regulation
• Participate in Sponsor Audit and Competent Authorities Inspections

Minimum requirements:

• Scientific Degree (ideally Master/ PhD in Biology, Biotechnology, Life Sciences, etc.)
• At least 3 years of experience in Clinical Quality maintenance and oversight 
• A high level of English language, both written and spoken
• Excellent interpersonal skills, ability to work in teams, flexibility in changing tasks and priorities and motivation for new challenges
• Preferred: qualified Auditor according to Italian Decree on CRO Minimum Requirements (15.11.2011)

Apply now