Regulatory Affairs Specialist jobs in California

Job Summary:
We are seeking a detail-oriented Regulatory Affairs Specialist to join our team. The ideal candidate will be responsible for ensuring compliance with all regulatory requirements related to our products and operations.

About Neurovision

Founded in 1973 on the principles of surgery and electrical engineering, we continue to pioneer intraoperative nerve monitoring technologies for the identification and preservation of motor nerves. Our mission is to provide leading-edge neuromonitoring surgical tools that empower clinicians to improve patient outcomes.

Neurovision Medical Products is located in Ventura, California, USA.

Position Title: Regulatory Affairs Specialist

Reports to: Director of Regulatory Affairs

Job Summary:

The Regulatory Affairs Specialist as part of a multifunctional team, will provide regulatory inputs throughout the medical device lifecycle in order for NMP to remain in compliance with all jurisdictional regulations.

Key Responsibilities

· Function as a Regulatory Affairs subject matter expert on various teams (product development, quality, manufacturing) or as a resource to department heads, providing input on regulatory requirements for all jurisdictions NMP must comply with. This includes conducting reviews and providing expert regulatory feedback for specifications, device testing, risk management, and other relevant documentation.

· Labeling and IFU

Manage the content for all labeling (IFUs and product labels) in the labeling software database and document control system in collaboration with cross-functional teams, e.g. Engineering, Clinical, database management, Regulatory submissions in accordance with ISO 15223-1:2021.

Review labeling, package inserts, promotional materials and company website to meet the FDA regulatory requirements

· Product Development

Provide input on regulatory Design and Development requirements

Assist research personnel, scientists, and risk management specialists, to ensure procedures around usability testing, clinical research and clinical evaluation are compliant with regulatory requirements and that carried out in accordance with those procedures.

· Post Market Surveillance

Manage the post market surveillance process for all products throughout product lifecycle, especially the communication and documentation chain from user feedback to relevant dept in QMS and ERP system.

Support preparation of materials, reports and follow-up with Regulatory Agencies regarding post market surveillance.

· Quality System

Perform regulatory research to inform strategy and keep regulatory sections of procedures in compliance.

Support quality system reporting to regulatory agencies for recall and adverse events.

Assist in the identification of, but not limited to, the following:

Relevant guidance documents, international standards, or consensus standards and their interpretation as they relate to registration requirements

Notification to management of new and revised documents referenced above

Other duties as assigned

Qualifications:

· Bachelor's Degree in science, engineering or related field

· 5 years of regulatory experience in a medical device development and lifecycle management

Essential Knowledge, Skills, and Abilities

· High aptitude with Microsoft Office suite, Microsoft project, electronic document control systems.

· High level of understanding of ISO 13485, ISO 14971, IEC 62366, CFR 21, MDD, MDR, ARGMD, CMDR required.

· Good level of understanding of IEC 60601 required.

· Strong project management, time management and organizational skills.

· Excellent verbal and written communication skills; strong attention to detail

· Must be highly organized with the ability to manage multiple projects/tasks simultaneously and effectively prioritize projects and tasks to meet deadlines.

· High Aptitude with learning new systems and processes, including software.

· Ability to problem solve and break down complex issues into manageable, resolvable tasks

· Approachable individual who provides a high level of teamwork and cross-functional collaboration

· High level of engagement in and interest for regulatory affairs.

· Experience with Labeling software systems a plus (eg. Loftware

Physical Demands

· Lift/Carry 15 lbs

· Screentime up to 8-10 hours a day

· Stand/Sit/Walk 8-10 hours a day

· Ability to use a keyboard for typing.

· Vision requirements correctable to 20/20 vision

Job Type: Full-time

Pay: $34.00 - $37.00 per hour

Expected hours: 37.5 per week

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Parental leave
• Vision insurance

Experience level:

• 5 years

Schedule:

• Day shift
• Monday to Friday

Experience:

• FDA regulations: 5 years (Preferred)

Ability to Commute:

• Ventura, CA 93001 (Required)

Ability to Relocate:

• Ventura, CA 93001: Relocate before starting work (Required)

Work Location: In person