Lead (Senior/Principal) Quality & Regulatory Affairs Specialist

Newport Beach, CA            ·            Full time

About the job

Lead (Senior/Principal) Quality & Regulatory Affairs Specialist Job Description

Wave Neuroscience is seeking an experienced Regulatory / Quality Assurance Principle Lead who can build upon this good reputation with an unwavering commitment to meticulous production. The ideal candidate is an exceptionally organized, methodical professional who has the experience necessary to take our products to the next level in accuracy, security, and safety. The specialist will be charged with developing a complete QA/RA program that not only safeguards product quality but also fosters a culture in which all employees are actively engaged.

Key Responsibilities:

• Lead, manage, improve, and maintain quality methodologies, processes, and procedures to ensure compliance with domestic (FDA) and international (EU/ISO) Quality System Regulations.
• Lead continuous quality improvement initiatives for all aspects of the company.
• Maintain risk analysis and risk management in accordance with regulatory requirements including FDA and ISO 14971.
• Develop, trend, and report key metrics monitoring the overall performance and functioning of the Quality System.
• Lead and coordinate activities for internal and external audits to establish and maintain compliance of the company’s Quality System.
• 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.
• 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 modifications.
• Ensure personal understanding and utilization of all quality policy/system items that are applicable to the role.
• Follow all work/quality procedures to ensure quality system compliance and high-quality work.
• Develop and maintain Quality and Regulatory affairs department procedures and process improvements.
• Assist in keeping company informed of regulatory requirements, including changes, in the markets of interest (currently the US and EU and subject to expansion).

Qualifications:

• 3+ years’ experience with FDA and ISO regulated product development, EU MDR and ISO Quality Systems, including Design Controls, Production and Process Controls, CAPA and complaints.
• Participation in 3+ regulatory submissions in the medical device industry, including Traditional and DeNovo (preferred) 510(k).
• Minimum Bachelor’s Degree (Computer Science, Biomedical Engineering or other life sciences)
• 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.
• 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 strongly preferred.
• Manage multiple projects simultaneously, identifying and prioritizing tasks to meet project schedules and company goals.

Please click here to apply.