What are the responsibilities and job description for the Regulatory and Quality Manager position at Private Medical Device Company?

Job Description

As the Regulatory and Quality Manager, you will be responsible for leading and / or supporting regulatory affairs and quality systems for the company. This role involves managing regulatory submissions, maintaining certifications, coordinating quality management systems (QMS), and ensuring that products meet both internal and external regulatory standards. The ideal candidate will have strong knowledge of regulatory frameworks, quality management systems, and industry standards related to medical devices.

Regulatory :

Develop and execute regulatory strategies to support the company's product development and market approval across domestic and international markets (FDA, CE, etc.).
Prepare, review, and submit regulatory filings (e.g., 510(k), Letter to File, ISO certifications) to ensure timely product approval.
Stay up-to-date with changing global regulations and industry standards to ensure compliance.
Work closely with R&D, engineering, and manufacturing teams to provide regulatory guidance throughout product development.
Manage interactions with regulatory agencies, including correspondence, audits, and inspections.
Oversee the preparation and maintenance of regulatory documentation, including technical files, design dossiers, and labeling.

Quality Management

Develop, implement, and maintain the company’s Quality Management System (QMS) to ensure compliance with ISO 13485 and other applicable standards.

Lead internal and external audits, inspections, and investigations to ensure continuous compliance with regulatory and quality requirements.

Conduct root cause analysis, CAPA (Corrective and Preventive Actions), and nonconformance investigations to resolve quality issues.

Monitor key quality performance metrics and provide recommendations for continuous improvement.

Establish and maintain supplier quality assurance processes, including audits, qualification, and management.

Support manufacturing teams with quality control processes, documentation, and inspections.

Required Qualifications :

Education : Bachelor’s degree in Engineering, Life Sciences, or a related field (Master’s preferred).

Experience : 5 years of experience in regulatory affairs and / or quality management, preferably in the medical device industry.

Strong knowledge of regulatory standards, including FDA, ISO 13485, MDR, and other relevant medical device regulations.

Proven experience with regulatory submissions, including 510(k) filings, PMA, CE marking, and international submissions.

Familiarity with quality system audits, risk management processes, and CAPA systems.

Experience working in a start-up or early-stage company is a plus.

Skills and Attributes :

Strong organizational, problem-solving, and communication skills.

Ability to work independently and manage multiple priorities in a fast-paced, dynamic environment.

Self-starter with demonstrated efficient work methods, analytical & problem-solving skills and ability to handle multiple tasks in a fast-paced environment.

Excellent communication skills and attention to detail.

Company Description

The company is a privately held medical device company that aims to improve the safety and efficacy of emergent neurosurgical procedures performed at the patient’s bedside. The company’s FDA cleared product is designed to provide intraoperative imaging and navigation in the ICU or trauma bay. You will be joining an energetic team to support the launch of a next gen product, while working with industry leading technology, in a fast-paced start-up environment.

Company Description

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Regulatory and Quality Manager

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