Job Description

Job Title: Senior Manager or Director, Regulatory Affairs and Quality Assurance

Location: Newport Beach, California (Hybrid Position, 3-4 Days On-Site)

About Hobson Associates’ Client:

Our client is seeking an experienced Regulatory Affairs Professional with strong, cross-function Quality Assurance ties who can lead these important arenas. The ideal candidate is an exceptionally organized, methodical professional who has the experience necessary to take our products to the next level in accuracy, integrity, security, and safety. This hire will help the company forward on its first FDA clearance, with QA program support that not only safeguards product quality but also fosters a culture in which all employees are actively engaged.

Key Responsibilities:

• Responsible for ensuring the preparation, drafting, and maintenance of quality documents (records, plans and reports) in support of regulatory (FDA & MDR) submissions to ensure timely approvals and market release of products. Provide support to currently-marketed products as necessary.
• Maintain risk analysis/management and cyber security in accordance with regulatory requirements including FDA and ISO 14971.
• Lead, manage, improve, and maintain quality methodologies, processes, and procedures to support regulatory submissions.
• Guide and support continuous quality improvement initiatives for all aspects of the company.
• Lead in keeping the company informed of regulatory requirements, including changes, in the markets of interest (currently the US and EU and subject to expansion).
• Develop, trend, and report key metrics monitoring the overall performance and functioning of the Quality System.
• Assist and coordinate activities for internal and external audits to establish and maintain compliance of the company’s Quality System.
• Work with advisors, legal, engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities as they relate to quality and regulatory activities. Take lead on cross-functional management and collaboration. May require project management skills in organizing critical path and setting timelines.
• Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
• Provide technical guidance on regulatory requirements for new technologies and product or process modifications.
• Ensure personal understanding and utilization of all quality policy/system items that are applicable to the role.
• Follow all procedures to ensure quality system compliance and high-quality work.
• Develop and maintain Quality and Regulatory affairs department procedures and process improvements.

Qualifications:

• Master’s Degree + (Computer Science, Biomedical Engineering or other life sciences) preferred
• Past experience with FDA and ISO regulated product development, EU MDR and ISO Quality Systems, including Design Controls, Production and Process Controls, CAPA and complaints.
• Demonstrated responsibilities related to 3+ regulatory submissions in the medical device industry, including Traditional and DeNovo (preferred) 510(k)’s.
• Experience working with regulatory documentation for devices that function as a system, including hardware, software, and algorithms. Experience working on Software as a Medical Device (SaMD) applied to biological systems strongly preferred.
• Excellent technical knowledge of the development and deployment of medical products (especially SW driven systems and SaMD) and understanding of relevant procedures, practices, and associated medical terminology.
• Manage multiple projects simultaneously, identifying and prioritizing tasks to meet project schedules and company goals.

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