Regulatory Compliance Specialist

6 days ago

San Diego, California, United States Modular Medical Inc Full time
Job Description

**Job Title:** Manager of Post Market Surveillance

**Job Category:** Exempt

**Department:** Quality Assurance

**Direct Report:** Director of Quality

**Location:** Not Specified

**Travel Required:** Up to 20%

**Salary Range:** $95,000 - $135,000

**Position Type:** Full-time/Onsite

Job Summary

Modular Medical Inc is seeking a highly experienced Quality Assurance Manager to lead our Post-Market Surveillance efforts. The successful candidate will be responsible for developing and implementing comprehensive quality assurance strategies, policies, and procedures to ensure compliance with applicable regulations and standards in the medical device industry.

Key Responsibilities
  • Develop and implement quality assurance strategies, policies, and procedures to ensure compliance with regulations and standards.
  • Collaborate with cross-functional teams to identify and address quality-related issues and drive continuous improvement.
  • Responsible for quality system improvements to gain certification to the ISO 13485 European standards and compliance to MDR 2017/745/EU.
  • Develop quality metrics and monitoring to present on an ongoing basis and feed into Management Reviews.
  • Act as a quality representative and liaison with contract manufacturing to ensure compliance with regulations.
  • Closely monitor established leading indicators, measure daily/weekly outputs, and plan activities to course-correct as needed to ensure overall timeliness metrics are sustained.
  • Develop and manage the overall post-market surveillance activities to ensure compliance with FDA MDR and other evolving regulatory requirements.
  • Identify and communicate emerging trends in post-market surveillance to drive product improvements.
  • Generate/update PMS system procedures as required (e.g., SQP, SOP, protocols, and reports).
  • Develop and maintain up-to-date knowledge on regulatory compliance, specifically FDA and EU requirements.
  • Work closely with other departments to set up quality files suitable for regulatory submissions.
  • All other duties as assigned.
Requirements
  • Bachelor's degree in engineering, science, or a related field.
  • Minimum of 10 years of experience in quality assurance in the medical device industry.
  • Proven track record of successful management of quality teams and implementing quality management systems in accordance with applicable regulations and standards.
  • In-depth knowledge of FDA regulations (e.g., 21 CFR Part 820), ISO standards (e.g., ISO 13485), and other applicable regulations and standards.
  • Experience leading product development teams and ensuring that products meet or exceed quality standards and customer expectations.
Skills
  • Ability to handle multiple tasks while ensuring timely and accurate completion.
  • Strong analytical and problem-solving skills, including the ability to conduct risk assessments and develop risk management plans.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and regulatory agencies.
Physical Demands
  • Ability to sit or stand for extended periods of time.
  • Ability to lift and/or move up to 35 pounds.

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