Company Overview:

Instru-Med is a leading contract manufacturer operating in accordance with ISO 13485 standards. We specialize in providing high-quality manufacturing solutions for medical devices. Our commitment to regulatory compliance and adherence to industry standards ensures the safety and efficacy of the products we produce.

Job Summary:

We are seeking a highly organized and detail-oriented Regulatory Compliance Administrator to join our team on a part-time basis (15-25 hours per week). The ideal candidate will be responsible for supporting regulatory compliance efforts, including the development and maintenance of standard operating procedures (SOPs), change management, audit preparation, and document retention. This role requires expert-level knowledge of MS Office products, strong familiarity with ISO 13485 requirements, and experience in areas such as GD&T (Geometric Dimensioning and Tolerancing), metrology (Calibration of Measurement Tools), and quality document control.

Key Responsibilities:

• Develop and revise standard operating procedures (SOPs) in accordance with ISO 13485 standards and regulatory requirements.
• Manage change control processes to ensure compliance with regulatory standards and maintain documentation integrity.
• Prepare for and assist with internal and external audits, including compiling documentation, facilitating audits, and addressing audit findings.
• Maintain document control systems to ensure accuracy, completeness, and accessibility of quality records.
• Provide support for regulatory submissions and certifications as needed.
• Collaborate with cross-functional teams to identify compliance gaps and implement corrective actions.
• Assist in the development and delivery of compliance training programs for employees.
• Stay informed about changes in regulatory requirements and industry best practices.

Qualifications:

• High School Diploma or equivalent work experience.
• Demonstrated experience in regulatory compliance within a manufacturing environment, preferably in the medical device or pharmaceutical industry.
• Expert-level proficiency in MS Office products, particularly Word, Excel, and Outlook.
• Understanding of ISO 13485 standards and quality management systems.
• Experience with SOP development and revision, change management, and audit preparation.
• Familiarity with GD&T (Geometric Dimensioning and Tolerancing) and metrology principles preferred.
• Solid understanding and adherence to Good Documentation Practices (GDP).
• Excellent organizational and time management skills with the ability to prioritize tasks effectively.
• Strong attention to detail and accuracy in documentation.
• Excellent communication skills, both verbal and written.
• Ability to work independently and collaboratively in a team environment.
• Flexibility to adapt to changing priorities and deadlines.
• This position offers a competitive hourly rate and the opportunity to contribute to the success of a dynamic and growing organization committed to quality and compliance excellence.

Instru-Med is an equal opportunity employer and values diversity in the workplace. We encourage candidates of all backgrounds to apply.

Job Type: Part-time

Pay: $12.00 - $18.00 per hour

Expected hours: 15 – 25 per week

Ability to Relocate:

• Warsaw, IN 46580: Relocate before starting work (Required)

Work Location: In person