ZipRecruiter is hiring: Regulatory Affairs Associate (Advertising...
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Overview
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Overview
Job Description
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.
You 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:
- 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:
- 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 areas are but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
- Communicate effectively verbally and in writing with diverse audiences and personnel. Write and edit technical documents.
- Work with cross-functional teams and people from various disciplines and cultures.
- Internal negotiation skills.
- Pays strong attention to detail.
- Manage projects. Create project plans and timelines.
- Analytical and critical thinking.
- Organize and track complex information.
- Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Applies business and regulatory ethical standards.
Qualifications:
- 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. 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, as well as principles and requirements of applicable product laws, promotional, advertising and labeling; domestic and international regulatory guidelines, policies and regulations, and ethical guidelines of the regulatory profession.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
- Office program skills to include Word, Excel, PowerPoint, Visio, and SharePoint.
Company Description:
Collabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud, and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom, and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.
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