Job Title: Regulatory Affairs ManagerJob DescriptionThis role leads the implementation and oversight of the regulatory system to ensure medical devices meet applicable domestic and international regulatory requirements while improving overall compliance and operational efficiency. The Regulatory Affairs Manager prepares and manages regulatory submissions for new and existing products, interfaces with regulatory agencies, and provides expert guidance to cross-functional teams on regulatory strategies, quality system regulations, and international standards. This position operates within the Quality and Regulatory department and holds authority for regulatory approvals related to reports, submissions, and device change files.
Responsibilities
- Prepare complete and accurate regulatory documents and submissions for new products under development and for changes to existing products, ensuring alignment with applicable regulations and guidance.
- Communicate proactively with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance testing requirements, and clarification or follow-up on submissions under review.
- Coordinate, prepare, or review regulatory submissions for domestic and international projects, ensuring consistency, scientific rigor, and timely delivery.
- Interpret new and existing regulatory rules, rule changes, and guidance documents, and translate them into clear internal policies, procedures, and work instructions.
- Provide technical review of data, reports, and supporting documentation to be incorporated into regulatory submissions to ensure scientific accuracy, completeness, and clarity.
- Review product promotional materials, labeling, batch records, specification sheets, and test methods for compliance with applicable regulations, quality system requirements, and company policies.
- Advise project teams on premarket regulatory requirements, export and labeling requirements, and clinical study compliance issues, helping to shape regulatory strategy throughout the product lifecycle.
- Determine the types of regulatory submissions or internal documentation required for proposed device changes or labeling changes, and ensure appropriate documentation is created and maintained.
- Identify relevant guidance documents, international standards, and consensus standards (such as FDA Quality System Regulations and ISO standards) and provide interpretive assistance to internal stakeholders.
- Prepare or coordinate the preparation of additional information, responses, and justifications as requested by regulatory agencies during review of submissions.
- Prepare, maintain, and update technical files and regulatory dossiers as necessary to obtain and sustain product approvals and ongoing regulatory compliance.
- Participate in or support internal audits and regulatory inspections by providing documentation, explanations, and evidence of compliance with applicable regulations and standards.
- Evaluate system performance indicators related to regulatory compliance and quality systems, and recommend or implement actions to improve or correct performance.
- Collaborate closely with quality, R&D, manufacturing, and other functions to ensure regulatory considerations are integrated into product design, development, and change control processes.
- Perform additional duties and projects as assigned by leadership to support the overall quality and regulatory strategy of the organization.
Essential Skills
- Bachelors degree in the sciences or a related field.
- At least 2 years of previous work experience in a similar regulatory position, preferably within medical devices or related regulated industries.
- Strong knowledge of regulatory requirements for Class II medical devices.
- In-depth knowledge of FDA Quality System Regulations (cGMP) and international standards pertaining to medical devices, including 21 CFR Part 820, ISO 13485, ISO 14971, and IVDR.
- Proficiency in Microsoft Word, Excel, and Outlook, with the ability to produce and manage complex regulatory documentation.
- Working knowledge of internet browsers such as Internet Explorer, Chrome, or Firefox.
- Ability and willingness to learn additional software programs as needed to support regulatory and quality activities.
- Knowledge of basic laboratory equipment and analytical instrumentation relevant to medical device development and testing.
- Effective verbal and written communication skills, with the ability to convey complex regulatory and technical information clearly to diverse audiences.
- Strong active listening skills, with the ability to fully understand stakeholder needs, ask clarifying questions, and respond thoughtfully.
- Demonstrated complex problem-solving skills, including the ability to identify issues, analyze data, evaluate options, and implement effective solutions.
- Sound judgment and decision-making abilities, with a focus on evaluating risks, benefits, and regulatory implications of potential actions.
- Experience in systems evaluation, including identifying measures or indicators of system performance and determining actions needed to improve or correct performance.
- Internal audit experience, particularly in regulated environments or quality management systems.
- Ability to define problems, collect data, establish facts, and draw valid conclusions using logical and scientific thinking.
- Strong math skills, including the ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume, and to apply concepts of basic algebra and geometry.
- Ability to work with mathematical concepts such as probability and statistical inference is preferred.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, technical journals, and governmental regulations in English.
- Ability to write high-quality regulatory submissions, reports, business correspondence, and procedure manuals in English.
- Ability to effectively present information and respond to questions from management, regulatory agencies, and customers, including responding to highly sensitive questions from regulators.
- Ability to use standard office equipment, including computers, copiers, scanners, fax machines, and telephone systems.
- Commitment to adhere to corporate personnel policies and practices, including reliable attendance and punctuality.
- Valid drivers license with a satisfactory driving record.
Additional Skills & Qualifications
- Experience working with FDA Quality System Regulations, 21 CFR Part 820, ISO 13485, ISO 14971, and IVDR in a practical, hands-on regulatory or quality role.
- Regulatory affairs experience specifically related to medical devices and in vitro diagnostics is highly beneficial.
- Familiarity with the preparation and maintenance of Design and Change Files (DACFs) or similar regulatory documentation sets.
- Experience supporting or leading interactions with regulatory agencies, including preparation of pre-submission packages and responses to agency questions.
- Experience reviewing and approving promotional materials and labeling for regulatory compliance.
- Demonstrated ability to interpret extensive technical instructions in mathematical or diagram form and to manage both abstract and concrete variables.
- Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
- Experience with probability, statistical inference, and data analysis in a regulatory or quality context is preferred.
- Knowledge of Microsoft Access or similar database tools is preferred.
- Ability to effectively present information to top management and cross-functional teams, influencing decisions with well-supported regulatory rationale.
- Strong organizational skills, with the ability to manage multiple projects and deadlines in a regulated environment.
- Motivation to work in a collaborative, team-oriented culture with a strong emphasis on quality, compliance, and continuous improvement.
Work EnvironmentThis position operates in an on-site, Monday through Friday day-shift environment, with flexibility provided as long as work is completed effectively and deadlines are met. The role is based in a team-oriented office and laboratory setting where the noise level is usually moderate. The Regulatory Affairs Manager regularly sits, stands, walks, uses hands, talks, and hears while performing daily tasks, and frequently reaches with hands and arms. The role occasionally requires stooping, kneeling, or crouching, and may involve lifting and moving up to 10 pounds. Specific vision abilities required include close vision, peripheral vision, depth perception, the ability to adjust focus, and the ability to distinguish colors, which are important for reviewing detailed documents and technical materials. The position relies on standard office technology, including computers, copiers, scanners, fax machines, and telephone systems, and may involve interaction with basic laboratory equipment and analytical instruments. The organization promotes a great culture and team environment, emphasizing collaboration, professionalism, and support for employees while maintaining high standards of regulatory compliance and product quality. Job Type & LocationThis is a Contract to Hire position based out of Davis, CA. Pay and BenefitsThe pay range for this position is $50.00 - $60.00/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 Leave) Job Type & LocationThis is a Contract to Hire position based out of Davis, CA. Application DeadlineThis position is anticipated to close on Nov 23, 2026. Workplace TypeThis is a fully onsite position in Davis,CA.About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
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Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
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