Regulatory Affairs Associate

ManpowerGroup; Alameda (CA); On-site; USD 48,000 - 55,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Regulatory affairs

Regulatory compliance

Cross-functional teamwork

Project management

Technical writing

Attention to detail

Analytical thinking

Verbal/written communication

Microsoft Office

Education

Bachelor's degree

Science degree (biology/chemistry/etc)

Tools

Word

Excel

PowerPoint

Visio

SharePoint

Job description

Title: Regulatory Affairs Associate

Location: Alameda, California (100% Onsite)

Duration: 8+ months

Shift Time: 8am to 5pm

Pay Range : $35/hr to $40/hr (On W2)

We are looking for a "Regulatory Affairs Associate" to join one of our Fortune 500 clients.

Job Responsibilities:

• 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.
• 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.
• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields.
• 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.
• Office programs skills to include Word, Excel, PowerPoint, Visio and SharePoint.

We are looking for the candidate who are eligible to work with any employers without sponsorship .

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.