Regulatory Affairs Specialist — Onsite in Alameda

ManpowerGroup; Alameda (CA); Sur place; USD 48 000 - 55 000; Plein temps

Résumé du poste

ManpowerGroup is seeking a Regulatory Affairs Associate for a Fortune 500 client in Alameda, California. The role is 100% onsite, 8:00 AM–5:00 PM, with a duration of 8+ months.

Pay ranges from $35 to $40 per hour on W2, and responsibilities include reviewing labeling and promotional materials for regulatory compliance and supporting submissions (510K/PMAs) as needed. The candidate should have a bachelor’s degree and at least 2 years in a regulated industry, strong communication, and the ability

Qualifications

• Bachelor's degree or equivalent combination of education and work experience.
• Minimum of 2 years' experience in a regulated industry (medical products, pharma, etc.).
• Strong verbal and written communication; ability to write/edit technical documents.
• Ability to work with cross-functional teams and diverse audiences.
• Detail-oriented with project management and timeline skills.
• Knowledge of labeling, promotional materials review and regulatory guidelines is desirable.

Responsabilités

• Review labeling, advertising and promotional materials for regulatory compliance.
• Assist with promotional content development and review for compliance.
• Assist in Regulatory Affairs SOP development and review.
• Support regulatory submissions (510K, PMA, Health Canada, Latin America) as needed.
• Determine and communicate promotional content approval requirements to cross-functional teams.
• Support post-marketing compliance activities as needed.

Connaissances

Regulatory affairs

Regulatory compliance

Cross-functional teamwork

Project management

Technical writing

Attention to detail

Analytical thinking

Verbal/written communication

Microsoft Office

Formation

Bachelor's degree

Science degree (biology/chemistry/etc)

Outils

Word

Excel

PowerPoint

Visio

SharePoint

Description du poste

ManpowerGroup is seeking a Regulatory Affairs Associate for a Fortune 500 client in Alameda, California. The role is 100% onsite, 8:00 AM–5:00 PM, with a duration of 8+ months.

Pay ranges from $35 to $40 per hour on W2, and responsibilities include reviewing labeling and promotional materials for regulatory compliance and supporting submissions (510K/PMAs) as needed. The candidate should have a bachelor’s degree and at least 2 years in a regulated industry, strong communication, and the ability