Regulatory Affairs Associate

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

The Opportunity

As an individual contributor in the function of a Regulatory Affairs Specialist you will provide support for the Regulatory Affairs department to ensure efficient and compliant business processes and environment. The individual may execute tasks and partner across business functions.

The individual will be reviewing Labeling, Advertising and Promotional materials, determining risk, identifying data needed, obtaining data and ensuring that the information is reliable and effectively presented to substantiate claims. You'll also have opportunities to participate in worldwide regulatory submissions.

This is a broad scoped position with strong opportunity for growth and career development based on performance.

What You’ll Work On – CAN ADD/CHANGE

• Review and analyze 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.

Required Qualifications – CAN’T CHANGE

• 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.

Preferred Qualifications – CAN ADD TO THIS SECTION

• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields.
• 1+ year of Regulatory Affairs or Quality experience within Medical Devices is preferred. Experience with review of labeling, promotional, and or advertising materials is highly desired.
• Prefer some knowledge of Regulatory and/or Quality Systems history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel; Principles and requirements of applicable product laws; Principles and requirements of promotion, advertising and labeling; Domestic and international regulatory guidelines, policies and regulations; Ethical guidelines of the regulatory profession, clinical research and regulatory process.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
• Office programs skills to include Word, Excel, PowerPoint, Visio and SharePoint.