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Part Time FDA Quality System Administrator

Boutique Recruiting

Posted on: 08 Mar 2024

Job Location: San Diego, US

Job Description:

A wellness company that develops products designed to enhance personal health and well-being is searching for a Part-Time FDA Quality System Administrator. This role is responsible for ensuring that all products are regulated properly, managing complaint and purchasing records, handling FDA audits and warning letters, assisting with labeling and marketing claims, and guiding the company in regulatory affairs for medical devices. The company has an open and comfortable work environment and offers a flexible part-time schedule, discretionary bonus and PTO for part-time employees!

Pay Range: $40 - $60/hr DOE

Responsibilities:

Ensure company wellness products meet regulatory standards and compliance requirements
Oversee and manage complaint and purchasing records effectively
Prepare for and manage external audits, responding to regulatory communications as needed
Assist with product labeling and marketing claims, ensuring compliance with all regulatory requirements
Offer guidance on product registrations and compliance issues to support company growth
Engage in training and collaborative meetings with internal teams and external partners to align regulatory strategies
Independently lead projects and offer regulatory guidance to senior management, contributing to strategic planning and compliance assurance

Requirements:

Minimum of 3 years of experience in regulatory affairs, preferably within the medical device sector
In-depth understanding of ISO 13485 and 21 CFR 820 quality systems
Proficiency in Microsoft Word and Excel is essential for day-to-day operations
A high school diploma is required - Bachelor's degree in a relevant field is preferred
Exceptional verbal and written communication skills
Detail-oriented with the ability to manage multiple priorities within deadlines
A professional demeanor that is comfortable working within the wellness and personal care industry
Discretion and sensitivity to customer needs and product confidentiality
While our customer base is diverse, preference will be given to candidates who can
Creative problem-solving skills and the flexibility to adapt processes and SOPs as needed to meet regulatory changes and business needs

Benefits:

Flexible, part-time hours
Comprehensive training
Casual work environment
Regular celebrations
PTO for part-time employees

To find out more about what this position has to offer you, apply now!

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