Director, Regulatory Counsel – MedTech & FDA Strategy

Edwards Lifesciences; San Diego (CA); Presencial; USD 174 000 - 246 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Relocation assistance

Resumo da oferta

Edwards Lifesciences in Irvine, CA is seeking a Director, Regulatory Counsel to lead regulatory review of advertising, provide strategic legal counsel to Marketing, Clinical Affairs and Regulatory Affairs, and help minimize risk across Edwards’ medical devices.

This in-person, full-time role offers relocation for qualified candidates and requires a JD with 8 years of experience in regulatory law, with ability to collaborate across business units.

Qualificações

• Juris Doctor from ABA-accredited law school with 8 years of legal experience.
• Strong written and verbal communication, and interpersonal skills.
• Ability to work under pressure and manage priorities.

Responsabilidades

• Review and approve advertising and promotional materials for compliance.
• Provide guidance on fraud and abuse issues.
• Review clinical contracts and regulatory matters.
• Assist with state licensing and sales contracting support.
• Develop standard processes and knowledge base for Healthcare Regulatory team.
• Deliver legal education on regulatory pathways and FDA investigations.
• Monitor regulatory developments affecting healthcare and medical devices.

Conhecimentos

Juris Doctor

8+ years experience

Regulatory law

Contract review

Communication skills

Formação académica

Juris Doctor (ABA-accredited)

Descrição da oferta de emprego

Edwards Lifesciences in Irvine, CA is seeking a Director, Regulatory Counsel to lead regulatory review of advertising, provide strategic legal counsel to Marketing, Clinical Affairs and Regulatory Affairs, and help minimize risk across Edwards’ medical devices.

This in-person, full-time role offers relocation for qualified candidates and requires a JD with 8 years of experience in regulatory law, with ability to collaborate across business units.