Regulatory Affairs Associate

Regulatory Affairs Specialist

The Regulatory Affairs Specialist plays a key role within the Quality and Regulatory department by implementing and overseeing the regulatory system to strengthen compliance and improve operational efficiency for medical device products, with a focus on Class II devices. This position prepares and manages regulatory submissions for new and existing products, interprets and applies regulatory requirements, and partners closely with internal teams and regulatory agencies to ensure products meet all applicable domestic and international standards.

Responsibilities

• Prepare complete and accurate regulatory documents and submissions for new products under development and for changes to existing products.
• Communicate proactively with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, required compliance testing, and clarification or follow-up for submissions under review.
• Coordinate, prepare, and review regulatory submissions for both domestic and international projects, ensuring timely and compliant delivery.
• Interpret regulatory rules, guidance documents, and rule changes, and translate them into clear internal policies, procedures, and work instructions.
• Provide technical review of data, reports, and supporting documentation to be included in regulatory submissions, ensuring scientific rigor, accuracy, and clarity.
• Review product promotional materials, labeling, batch records, specification sheets, and test methods to verify compliance with applicable regulations, standards, and internal policies.
• Advise cross-functional project teams on premarket regulatory requirements, export and labeling requirements, and clinical study compliance issues.
• Determine the appropriate types of regulatory submissions or internal documentation required for proposed device modifications or labeling changes.
• Identify relevant guidance documents, international standards, and consensus standards, and provide interpretive assistance to internal stakeholders.
• Prepare or coordinate the preparation of additional information and responses requested by regulatory agencies during the review process.
• Prepare, organize, and maintain technical files and regulatory documentation necessary to obtain and sustain product approvals and certifications.
• Conduct and support internal audits related to regulatory and quality system requirements, and contribute to corrective and preventive actions.
• Evaluate systems and processes, identify performance indicators, and recommend actions to improve or correct performance relative to regulatory and quality goals.
• Define problems, collect data, establish facts, and draw valid conclusions to support regulatory decision-making and problem resolution.
• Apply logical and scientific thinking to interpret complex technical instructions and manage multiple abstract and concrete variables.
• Collaborate effectively in a team environment, contributing to a positive culture and strong cross-functional relationships.
• Use basic office equipment and software to create, manage, and store regulatory documentation and correspondence.
• Perform additional duties as assigned by supervisory or management personnel in support of quality and regulatory objectives.

Essential Skills

• Bachelors degree in a scientific discipline or a related field.
• At least 2 years of previous work experience in a similar regulatory position, preferably within the medical device industry.
• Solid knowledge of regulatory requirements for Class II medical devices.
• Strong understanding of FDA Quality System Regulations (cGMP) and related international standards for medical devices, including 21 CFR Part 820.
• Knowledge of ISO 13485 and ISO 14971 standards and their application to medical device quality and risk management systems.
• Familiarity with basic laboratory equipment and analytical instrumentation relevant to medical device development and testing.
• Proficiency in Microsoft Word, Excel, and Outlook for preparing documents, reports, and correspondence.
• Ability to use web browsers such as Internet Explorer, Chrome, or Firefox to research regulatory information and access online systems.
• Effective verbal and written communication skills, with the ability to convey complex regulatory information clearly to diverse audiences.
• Strong active listening skills, with the ability to fully understand stakeholder needs, ask clarifying questions, and respond appropriately.
• Demonstrated complex problem-solving skills, including the ability to analyze issues, evaluate options, and implement effective solutions.
• Sound judgment and decision-making ability, considering the relative risks and benefits of potential actions to choose appropriate regulatory strategies.
• Systems evaluation skills, including the ability to identify performance measures and recommend improvements to regulatory and quality systems.
• Internal audit experience related to regulatory compliance or quality systems.
• Ability to read, analyze, and interpret business periodicals, professional journals, technical procedures, technical journals, and governmental regulations in English.
• Ability to write clear and comprehensive regulatory submissions, reports, business correspondence, and procedure manuals in English.
• Ability to effectively present information and respond to questions from managers, regulatory agencies, customers, and senior leadership.
• Ability to respond professionally to sensitive questions from regulatory agencies and other external stakeholders.
• Strong reasoning skills, including the ability to define problems, collect data, establish facts, and draw valid conclusions.
• Mathematical skills, including the ability to calculate figures such as discounts, interest, proportions, percentages, area, circumference, and volume, and apply basic algebra and geometry.
• Ability to work with mathematical concepts such as probability and statistical inference.
• Commitment to adhering to corporate personnel policies and practices, including reliable attendance and punctuality.
• Valid drivers license with a satisfactory driving record.

Additional Skills & Qualifications

• Experience preparing and managing regulatory submissions for domestic and international markets.
• Experience interacting directly with regulatory agencies on pre-submission strategies, submission reviews, and follow-up inquiries.
• Ability to interpret and apply guidance documents, international standards, and consensus standards to product and process requirements.
• Experience reviewing product labeling, promotional materials, batch records, and test methods for regulatory compliance.
• Ability to manage multiple projects simultaneously while maintaining attention to detail and meeting deadlines.
• Comfort working with technical instructions in mathematical or diagram form and handling several abstract and concrete variables.
• Ability to apply principles of logical and scientific thinking to regulatory and quality challenges.
• Experience with ISO-based quality management systems, particularly ISO 13485 for medical devices.
• Familiarity with risk management practices aligned with ISO 14971.
• Knowledge of FDA Quality Systems regulations and broader regulatory frameworks related to medical devices.
• Willingness and ability to learn new software programs and tools as needed to support regulatory activities.
• Strong collaboration skills and the ability to contribute positively to a team-oriented culture.
• High level of professional integrity and attention to detail in documentation and communication.
• Ability to adapt to changing regulatory requirements and organizational priorities.

Work Environment

This is an exempt, full-time, onsite role working Monday through Friday on a day shift schedule, with flexibility as long as work commitments are met. The position is based in a team-oriented environment with a generally moderate noise level, fostering a supportive culture and strong collaboration among colleagues. The role involves regular periods of sitting, standing, and walking, as well as frequent use of hands to handle documents and operate office equipment such as computers, copiers, scanners, fax machines, and telephones. Occasional reaching with hands and arms, stooping, kneeling, or crouching may be required, along with occasionally lifting or moving items up to 10 pounds. Visual requirements include close vision, peripheral vision, depth perception, the ability to adjust focus, and color vision to review detailed documentation and product materials. The organization emphasizes a great culture and team environment, offering a professional setting where flexibility, accountability, and collaboration are highly valued.

Job Type & Location

This is a Contract to Hire position based out of Davis, CA.

Pay and Benefits

The pay range for this position is $40.00 - $45.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick