Senior Advisor, Regulatory and Clinical Affairs

🕒 Fevereiro 4

🏄 California, Connecticut, +1 estados a mais – Remoto

🏄 California – Remote 🦌 Connecticut – Remote ❄️ Minnesota – Remote

💵 $183.000 - $228.800 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

Candidatar-se

Encontrar Vagas Remotas Similares

Receber Emails de Vagas Remotas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

ZEISS Group

SiteLinkedInTodas as Vagas

10.000+ funcionários

A ZEISS é uma empresa de tecnologia líder internacionalmente, operando nos campos de óptica e optoeletrônica. No exercício fiscal anterior, o Grupo ZEISS gerou uma receita anual totalizando 10 bilhões de euros em seus quatro segmentos: Tecnologia de Fabricação de Semicondutores, Qualidade Industrial & Pesquisa, Tecnologia Médica e Mercados de Consumo (status: 30 de setembro de 2023). Com cerca de 43.000 funcionários, a ZEISS está presente globalmente em quase 50 países, com cerca de 30 locais de produção, 60 empresas de vendas e serviços e 27 instalações de pesquisa e desenvolvimento (status: 30 de setembro de 2023). Fundada em 1846 em Jena, a empresa tem sua sede em Oberkochen, Alemanha. A Carl Zeiss Foundation, uma das maiores fundações da Alemanha dedicada à promoção da ciência, é a única proprietária da holding Carl Zeiss AG. Privacidade de dados: www.zeiss.com/data-protection Impressum: http://zeiss.com/publisher Esta é a conta oficial da ZEISS no LinkedIn. Ela segue a Netiqueta ZEISS: www.zeiss.com/netiquette

Descrição

• Provide input to regulatory and clinical strategies of all CZM products for the US market to ensure adequate and most efficient 510ks, PMAs, and IDEs • Participate in strategy and management meetings, as needed to provide guidance and Agency perspective • Demonstrated expertise in the design and implementation of complex clinical strategies to support global regulatory and market needs. • Expertise in the design and execution of clinical studies which optimize the use of clinical data for global product approvals • Coach / train CZM organizations on US requirements (e.g. product design / design controls, clinical requirements, marketing material review et al.) • Review product claims and plans for substantiation of those, and decides upon adequacy of claim substantiation • Prepare and participate in meetings with US FDA • Conclude on adequacy of promotional and educational materials for appropriate regulatory content in case of unclear aspects. • Support Product Complaint investigations, as required. • Support BIMO audits, as needed • Driving resolutions of questions from FDA, pre- and post-market

🎯 Requisitos

• Master’s degree with emphasis in the Physical Sciences, Mathematics, Statistics, or Engineering with a strong clinical foundation required. • Strongly prefer O.D., Ph.D. or M.D. • Thought leader in the Ophthalmology and/or vision science fields and recognized for their contributions and/or publications in the field. • Fifteen (15) years of experience in an FDA-regulated environment (or 8+ years with M.D.). • At least fifteen (15) years demonstrated experience with FDA, or working relationship with FDA (or 8+ years with M.D.). • Direct experience working at the Agency is strongly preferred. • Must have excellent communication skills, both written and oral, and must be computer literate. • A strong background in refractive surgery, IOL technology, vision science and statistical analysis is desirable.

🏖️ Benefícios

• Medical • Vision • Dental • 401k Matching • Employee Assistance Programs • Paid time off including vacation, personal, and sick days