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Regulatory Affairs Specialist – Medical Devices
Middle (2-5 years)
Mission and purpose of position:
Reporting to the Head of RA Europe, performs all necessary regulatory activities for Bausch + Lomb medical devices in the Romanian market. Ensures timely notification of all medical devices to the Romanian Health Authority in compliance with national legislation and European Directives and Regulations. Develops processes to ensure that all medical devices on the Romanian market are maintained in compliance throughout the product lifecycle. Partnering closely with the commercial organisation in CEE, acts as the primary point of contact for all medical devices in the Romanian market.
Responsibilities and obligations:
- Cooperation with local Authorities
- Notification of all medical devices in Romania to the health authority
- Reviewing and approving advertising and promotional materials
- Conducting Change evaluations for impact to the Romanian market
- Maintaining the import and distribution authorization for medical devices
- Supporting tenders
- Working with Distributors to ensure regulatory compliance
- Verifying packaging and labelling artwork meets local requirements
- Supporting Field Safety Corrective Actions
- Updating and maintaining the quality management system
- Monitoring of MDR implementation
- Staying current on national and European legislation
- Participating in regulatory policy and intelligence activities
- Organizing and participating in internal and external audits
- Managing complaints, medical enquires and recalls
- Maintaining internal databases
- Managing Quality Agreements related to MD
- Providing relevant training to newcomers and annual trainings
- Appropriate archiving of documentation and correspondence
- Supporting regional/global projects as applicable
- Supporting local regulatory affairs and medical affairs position
Requirements to the candidates:
- At least 2-3 years of experience in regulatory affairs, quality or compliance with Medical Devices.
- Bachelor’s degree in science, engineering, pharmacy, medicine or another related field; Advanced degree preferred (MS, PharmD, . or equivalent);
- Strong knowledge of legislation for Medical devicesEEC) and (EU;
- Capability to react quickly to changes in the regulatory environment;
- Self-motivated, detail-oriented and capable of working independently;
- Demonstrated ability in analytical reasoning and critical thinking skills;
- Fluent written and spoken Romanian and English;
- Experience working in cross-functional teams.
- Work in an international company with market-leading positions in Europe and around the world.
- Contract for indefinite period with 3 months of probation period
- A positive and supportive team of professionals.
All applicants will be treated confidentially and in accordance to all personal data protection requirements.