Risk Management Junior

JR Italy; Cremona; In loco; EUR 35.000 - 55.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Risk Management Analyst MD to enhance product safety and compliance within the medical device sector. In this role, you will support vital risk management processes, ensuring adherence to regulatory guidelines while collaborating on product development. Your expertise will help maintain quality and safety throughout the product lifecycle. This is an exciting opportunity to contribute to innovative solutions that improve patient outcomes in a dynamic and supportive environment. If you have a scientific background and a passion for regulatory excellence, this role is perfect for you.

Competenze

• Professional experience in regulatory or quality roles within medical or pharmaceutical companies.
• Knowledge of NMPA, MDD, MDR, ISO13485, ISO14971.

Mansioni

• Support planning and maintenance of risk management processes.
• Participate in product development and design reviews.
• Draft and support the creation of post-market reports.

Conoscenze

Regulatory Compliance

Risk Management

Quality Assurance

Medical Device Regulations

ISO Standards

Formazione

Scientific Degree

Descrizione del lavoro

Grafton LifeScience - Risk Management Analyst MD

Grafton LifeScience, a specialized team within Gi Group Spa authorized by the Ministry of Labour, focuses on enhancing the careers of candidates in Sales & Marketing, Clinical Research, Regulatory, and Operations within the Pharmaceutical and Medical sectors. We support candidates in finding roles that match their skills and expectations, particularly in customer service for distribution channels impacting health (Pharmacies and Parapharmacies).

We are currently seeking a Risk Management Analyst MD for a leading global company providing products and services for individuals with renal insufficiency.

Responsibilities

• Support planning and maintenance of risk management processes, including risk analysis for medical devices in compliance with regulatory guidelines.
• Ensure activities are executed according to the risk management plan.
• Participate in product development and design reviews to ensure risks are properly evaluated and addressed.
• Plan and review risk assessments.
• Reconcile risk analysis with defect management during pre-production (anomaly reports).
• Assist in preparing FMEAs and anomaly reports.
• Maintain the risk management file throughout the product lifecycle.
• Support risk evaluation processes within the quality system (e.g., complaints, non-conformities, CAPA).
• Draft and support the creation of post-market reports (e.g., PSUR, CER).

Candidate Profile

Scientific degree with professional experience in regulatory or quality roles within medical or pharmaceutical companies. Knowledge of NMPA regulation, MDD 93/42/EEC, MDR 2017/745, MDSAP, ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CFR §820, 806, 803.

Details

Working hours: Monday to Friday, flexible hours 8:00-9:00 / 17:00-18:00.

Contract offer: 12-month fixed-term contract via agency, CCNL Gomma e Plastica - Industria.

Location: Palazzo Pignano (CR).

If you believe you have the skills and attitude for this role, please submit your application!

Grafton LifeScience is a specialized branch of Gi Group Spa, authorized by the Ministry of Labour and Social Policies (Aut. Min. 26/11/2004 PROT. 1101 - SG).

The offer is aimed at candidates in compliance with Legislative Decree no. 198/2006 and subsequent amendments, and Legislative Decrees no. 215 and 216 of 2003 regarding equal treatment.

Applicants are invited to read the privacy policy pursuant to Articles 13 and 14 of EU Regulation 679/2016 at www.gigroup.it/privacy-candidati.

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