Regulatory Conformity Specialist Italy
4 settimane fa
The Opportunity
Ortho Clinical Diagnostics unites the strengths of a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry, and transfusion medicine.
Our culture prioritizes actions that support happiness, inspiration, and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked.
Your new role
You will be responsible for ensuring conformity of regulatory processes and strategies to local and international regulations as well as Ortho Clinical Diagnostics standards.
Key responsibilities include:
- Contributing to the development and implementation of regulatory strategies.
- Managing communications with regulatory agencies, customers, and the Strasbourg Center of Excellence.
- Managing the roll-out of field safety corrective actions and field actions in collaboration with global Quality, Regulatory & Compliance functions.
- Managing the Quality Management System in alignment with the EMEA Quality strategy.
- Supporting commercial processes, including review and approval of promotional material.
- Providing quality and regulatory input to tenders and customer contracts.
- Supporting internal, external, and supplier audit programs.
- Managing product registration/notification in the Italian Repository of the MoH.
What you'll be doing
- Supporting commercial business through the completion and maintenance of tender submissions and customer contracts.
- Rolling out field actions and global customer communications to authorities and customers.
- Monitoring regulatory requirements and ensuring conformity to those.
- Performing post-market surveillance activities.
- Acting as a contact person, liaison with local health representatives, and representing Ortho Clinical Diagnostics in local regulatory associations.
What you'll need to succeed
- Technical degree or diploma in chemistry, biochemistry, biology, pharmacy, engineering, or a related field.
- 3-5 years of previous experience in a similar position in a regulated industry.
- Independent working ability.
- Strong communication skills.
- Strong knowledge of Italy regulations and local compliance.
- Good knowledge of the IVD medical device regulatory environment.
- Experience in managing quality systems (ISO 9001-ISO 13485 standards).
- Fluent in English and Italian.
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