Senior Medical Writer & Regulatory Submissions Lead

Thornton Tomasetti; Santa Clara (CA); Presencial; USD 90 000 - 180 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Career development

Health coverage

Retirement plan

Tuition reimbursement

Diversity and inclusion awards

Resumo da oferta

Abbott is seeking a Senior Medical Writer / Senior Project Manager, Clinical Evaluation to join our Vascular Division on-site in Santa Clara, CA or Maple Grove, MN. The role combines clinical evaluation, regulatory expertise, and project leadership to support CE marking and EU MDR compliance.

The candidate will develop CERs and SSCPs, review evidence from literature and investigations, and lead regulatory responses with internal teams and CROs. Travel <10% may be required.

Qualificações

• Bachelor’s degree required in science, engineering, or medical field.
• Thorough understanding of EU MDR 2017/745, MDD, and MEDDEV guidelines.
• Strong project management experience.
• Excellent written, verbal and presentation skills in clinical/technical domains.
• Ability to travel up to 10%.
• Experience in clinical research/regulatory affairs is preferred.

Responsabilidades

• Create and maintain Clinical Evaluation Plans and Reports.
• Summarize clinical evidence from investigations, literature, and post-market data.
• Support regulatory submissions and CE marking activities.
• Coordinate cross-functional teams and document exchange.
• Provide strategic guidance on regulatory requirements for new products.
• Manage timelines and budgets for CER-related work.

Conhecimentos

Clinical writing

Project management

Regulatory affairs

Scientific background

Communication skills

Travel (<10%)

Formação académica

Bachelor's degree

Master’s degree / MD / PhD preferred

Descrição da oferta de emprego

Abbott is seeking a Senior Medical Writer / Senior Project Manager, Clinical Evaluation to join our Vascular Division on-site in Santa Clara, CA or Maple Grove, MN. The role combines clinical evaluation, regulatory expertise, and project leadership to support CE marking and EU MDR compliance.

The candidate will develop CERs and SSCPs, review evidence from literature and investigations, and lead regulatory responses with internal teams and CROs. Travel <10% may be required.