Specialist, Regulatory Affairs
Type
Full time
Location
Job reference
Req-37240
Posted for
21 days ago
Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives.
How you’ll make an impact:
• Prepare and complete product registration tasks covering the new product registration, the registration amendment, and the renewal registration. Ensure product tests/samples meet safety and performance requirements of regulatory agencies in collaboration with lab technicians
• Prepare clinical trial and evaluation report applications according to government regulations, hospital ethics committee needs, and company requirements for submission
• Create local language labels and Instruction For Use in compliance of country regulations before passing them to Supply Chain
• Liaise with regulatory agencies to facilitate and expedite review and approval of company products, registrations, submissions, reformulations etc
• Maintain proper records in the Module Change Request and JDE system to comply with local and company regulatory and quality requirements
• Serve as regulatory liaison throughout product lifecycle. Participates in regulatory strategy and operating plans
• Handle product recall reporting to regulatory agencies, for products exhibiting non-compliance
• Review marketing advertisements to ensure compliance to regulations and submit to FDA for approval
• Other incidental duties: Serve as regulatory representative to sales & marketing team, clinical team and regulatory agencies.
What you'll need (Required):
Bachelor's Degree in related field, 3 Years years experience Previous related experience.Coursework, seminars, and/or other formal government and/or trade association training Required and
Other: in Scientific discipline (e.g., Biology, Microbiology, Chemistry) Experience in preparing domestic and international product submissions Preferred
What else we look for (Preferred):
• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving, organizational, analytical and critical thinking skills
• Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
• Solid knowledge and understanding of global regulatory requirements for new products or product changes.
• Solid knowledge of new product development systems
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Work is performed independently on complex projects and/or lines of work and reviewed for accuracy and soundness
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Aviso importante para las candidatos y candidatas
Requisito de vacunación COVID
Edwards se compromete a cumplir con los requisitos y orientaciones de nuestras autoridades gubernamentales y a proteger a nuestros pacientes vulnerables y a los proveedores de atención sanitaria que los tratan en todo el mundo. Como tal, todos los puestos de trabajo que interactúan con la atención sanitaria requieren la vacunación COVID-19, lo que incluye a cualquier persona que interactúe directamente con los pacientes y a aquellos que interactúan con los proveedores de atención sanitaria como parte de su función. En caso de ser contratado, como condición para el empleo, se le pedirá que presente una prueba de que se ha vacunado completamente contra la COVID-19 o que tiene una exención religiosa o médica válida para no vacunarse. Este requisito de vacunación no se aplica en los países en los que está prohibido por ley imponer la vacunación. En los países en los que las vacunas están menos disponibles, o en los que existen otros requisitos, podemos instituir medidas alternativas que optimicen la seguridad del paciente y del personal sanitario, que pueden incluir pruebas periódicas de COVID o requisitos específicos de enmascaramiento.
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