Regulatory Affairs Associate: Global Compliance & Submissions

Talentburst,-Inc; Alameda (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Talentburst, Inc. is seeking a Regulatory Affairs Specialist to support the Regulatory Affairs department in ensuring compliant business processes.

You will review labeling, advertising, and promotional materials, assess risk, gather data, and help substantiate claims, with opportunities to participate in worldwide regulatory submissions. This is a broad role with room to grow; you will collaborate with Marketing and cross-functional teams, translate regulatory requirements into practical

Qualifications

• Bachelor's degree or an equivalent combination of education and work experience.
• Minimum of 2 years’ experience in a regulated industry (e.g., medical products, nutritionals, pharma, food). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents.
• Work with cross-functional teams. Work with people from various disciplines and cultures.
• Write and edit technical documents.
• Negotiate internally.
• Pay strong attention to detail.
• Manage projects. Create project plans and timelines.
• Think analytically and critically.
• Organize and track complex information.
• Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Apply business and regulatory ethical standards.

Responsibilities

• Review labeling, advertising and promotional materials while working with Marketing teams to provide regulatory strategy and compliance input.
• Assist with promotional content development and review for compliance before distribution.
• Assist in Regulatory Affairs Ad & Promo SOP development and review.
• Assist with activities related to NPI and on market products (510K, PMA, Health Canada submissions and Latin America countries) as needed
• Determine and communicate promotional content and approval requirements to cross functional teams.
• Assist compliance with product post-marketing approval requirements as needed.

Skills

Regulatory knowledge

Technical writing

Cross-functional collaboration

Project management

Attention to detail

Negotiation

Education

Bachelor's degree or equivalent

Tools

Word

Excel

PowerPoint

Visio

SharePoint

Job description

Talentburst, Inc. is seeking a Regulatory Affairs Specialist to support the Regulatory Affairs department in ensuring compliant business processes.

You will review labeling, advertising, and promotional materials, assess risk, gather data, and help substantiate claims, with opportunities to participate in worldwide regulatory submissions. This is a broad role with room to grow; you will collaborate with Marketing and cross-functional teams, translate regulatory requirements into practical