Regulatory Affairs Specialist
Il y a 2 mois
**About the job**:
As a total solution provider of medical devices and pharmaceutical packaging, Nipro Europe Group Companies is continuously committed to improving patient outcomes and quality of life. We are part of a large global network headed by Nipro Corporation Japan, an industry-leading healthcare company with over 35.000 employees worldwide. Our European headquarters in Mechelen, Belgium covers a wide geographical reach (Europe, Africa, India, the Americas) and is home to Nipro Medical Europe NV, Nipro PharmaPackaging International, and the Institute for Medical Practice (iMEP) Belgium.
Join our dynamic team at **Nipro Medical Europe NV**, a leading innovator in the medical device industry. We are committed to improving patient outcomes and transforming healthcare through our cutting-edge technologies. With a commitment to excellence and a focus on improving patient lives, we are seeking a talented **Regulatory Affairs Specialist** to support our operations in the Eurasian Economic Union (EAEU) and Eastern Europe (EE) region.
**About the Role**:
As a **Regulatory Affairs Specialist**, you are responsible for Market Authorization process of Medical Devices and _in vitro_ Diagnostics within Nipro Medical Europe NV Eastern Europe and EAEU Territories.
**What you’ll do**:
Regulatory compliance
- Perform full analysis of product registrations and build registration plan accordingly.
- Lead the execution and delivery of the registration plan for Eastern Europe and EAEU and review product technical files in accordance with local regulatory requirements.
- Coordinate and interact with Internal (Operations, Sales and Marketing) and External Stakeholders (Legal manufacturers, local distributors, Competent authorities) for the preparation of registration dossiers to meet the submission timelines.
- File, maintain and organize local registration submissions and maintain regulatory flags within SAP system in conjunction with Order Management team.
- Act as the primary contact with Eastern European and EAEU Competent Authorities on market clearance activities, ensuring ongoing market access in line with business strategy.
- Support the execution of submission strategies and registration planning in Eastern Europe and EAEU in collaboration with RA leadership.
- Monitor regulatory changes across EAEU and escalate to RA leadership as necessary.
- Develop, implement and maintain compliant, harmonized, best practice market clearance/registration processes in Eastern Europe and EAEU.
- Build, implement and maintain effective local product registration processes. Describe in bullet points the major duties / tasks this function is responsible for.
Change Management Process
- Review product change notifications issued by international manufacturing sites, evaluates re-registration requirements, and communicates to regulatory team.
- Execute re-registration as an outcome of product and/or regulation changes when applicable.
- Ensure that product version delivered in Eastern Europe and EAEU is the same as the registered version.
- Keep an overview of all related product change documents.
**What You’ll Need**:
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Regulatory Affairs, or related field.
Regulatory Knowledge:
- Familiarity with Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on _in vitro_ diagnostic medical devices, CE Marking process, and ISO standards.
- Understanding of classification systems for medical devices (Class I, IIa, IIb, or III).
Technical Writing and Documentation:
- Ability to write, analyse, and edit technical documents for regulatory submissions.
- Proficiency in maintaining regulatory files and authorizations.
Attention to Detail and Compliance:
- Meticulous attention to detail when handling regulatory documents.
- Commitment to maintaining compliance with regulations.
Communication and Interpersonal Skills:
- Effective communication with cross-functional teams, regulatory authorities, and external partners.
- Collaboration with other departments to gather necessary information.
Problem-Solving and Adaptability:
- Ability to address regulatory challenges and find solutions.
- Adaptability to evolving regulations and industry trends.
Ethical Conduct:
- Upholding ethical standards in all interactions related to medical devices.
**What We’ll Offer**:
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