Regulatory Affairs Associate Global Submissions & Labeling

Spectraforce Technologies, Inc.; Alameda (CA); Presencial; USD 70 000 - 100 000; Tempo integral

Resumo da oferta

Spectraforce Technologies, Inc. seeks a Regulatory Affairs Associate in Alameda, CA for a 10+ month assignment. You will support Regulatory Affairs to ensure compliant business processes and may work with multiple functions.

You’ll review labeling, advertising and promotional materials for regulatory risk, assist with submissions (510K, PMA, Health Canada) and help develop SOPs. Ideal candidate has a Bachelor's and at least 2 years in a regulated industry, strong written and verbal

Qualificações

• Bachelor's degree or equivalent combination of education and work experience.
• Minimum of 2 years' experience in a regulated industry.
• Effective verbal and written communication with diverse audiences.
• Work with cross-functional teams.
• Write and edit technical documents.
• Strong attention to detail and project management.
• Think analytically and organize complex information.
• Exercise judgment within defined practices and policies.
• Apply business and regulatory ethical standards.

Responsabilidades

• Review labeling, advertising and promotional materials for regulatory input.
• Assist with promotional content development and review for compliance.
• Help develop Regulatory Affairs SOPs and reviews.
• Support activities related to NPI and on-market products (510K, PMA, Health Canada, LATAM).
• Communicate approval requirements to cross-functional teams.
• Ensure post-marketing compliance with regulatory requirements.

Conhecimentos

Cross-functional teamwork

Attention to detail

Project management

Analytical thinking

Written communication

Negotiation

Formação académica

Bachelor's degree or equivalent

Bachelor's degree in science

Ferramentas

Word

Excel

PowerPoint

Visio

SharePoint

Descrição da oferta de emprego

Spectraforce Technologies, Inc. seeks a Regulatory Affairs Associate in Alameda, CA for a 10+ month assignment. You will support Regulatory Affairs to ensure compliant business processes and may work with multiple functions.

You’ll review labeling, advertising and promotional materials for regulatory risk, assist with submissions (510K, PMA, Health Canada) and help develop SOPs. Ideal candidate has a Bachelor's and at least 2 years in a regulated industry, strong written and verbal