Regulatory Affairs Specialist

Regulatory Affairs Specialist

Job Description

The Regulatory Affairs Specialist plays a key role in implementing and overseeing the regulatory system to strengthen compliance and improve operational efficiency for medical device products, with a particular focus on Class II devices. This position works within the Quality and Regulatory department and collaborates closely with cross-functional teams to prepare and manage regulatory submissions, maintain product approvals, and ensure that company practices align with FDA Quality System Regulations and relevant international standards.

Responsibilities

• Prepare regulatory documents and submissions for new products under development and for changes to existing products.
• Communicate 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 to support product approvals and market access.
• Interpret regulatory rules, guidance, and rule changes, and ensure they are effectively translated into internal policies and procedures.
• 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 for compliance with applicable regulations and internal policies.
• Advise project teams on premarket regulatory requirements, export and labeling requirements, and clinical study compliance issues.
• Determine the types of regulatory submissions or internal documentation required for proposed device or labeling changes.
• Identify relevant guidance documents, international standards, and consensus standards, and provide interpretive assistance to internal stakeholders.
• Prepare or coordinate responses and additional information requested by regulatory agencies during the review process.
• Prepare, organize, and maintain technical files and regulatory documentation necessary to obtain and sustain product approvals.
• Exercise regulatory approval authority for designated reports, submissions, and related documentation within the defined scope of authority.
• Participate in internal audits and support continuous improvement of regulatory and quality systems.
• Perform additional duties as assigned by supervisory or management personnel to support departmental and organizational goals.

Essential Skills

• Bachelor’s degree in the sciences or a related field.
• At least 3 years of previous work experience in a similar regulatory position.
• Knowledge of regulatory requirements for Class II medical devices.
• Knowledge of FDA Quality System Regulations (cGMP) and medical device regulations, including 21 CFR Part 820.
• Knowledge of international standards related to medical devices, such as ISO 13485 and ISO 14971.
• Knowledge of basic laboratory equipment and analytical instrumentation.
• Proficiency in Microsoft Word, Excel, and Outlook.
• Ability to use common internet browsers such as Internet Explorer, Chrome, or Firefox.
• Strong written communication skills, including the ability to write regulatory submissions, reports, business correspondence, and procedure manuals in English.
• Ability to read, analyze, and interpret professional journals, technical procedures, technical journals, general business periodicals, and governmental regulations in English.
• Ability to effectively present information and respond to questions from managers, regulatory agencies, and customers in English.
• Ability to respond to sensitive questions from regulatory agencies and present information to senior leadership.
• Effective verbal communication skills and the ability to convey information clearly to others.
• Active listening skills, including the ability to give full attention, ask appropriate questions, and avoid inappropriate interruptions.
• Complex problem-solving skills, including the ability to identify complex issues, evaluate options, and implement effective solutions.
• Sound judgment and decision-making skills, with the ability to weigh risks and benefits to choose appropriate actions.
• Systems evaluation skills, including the ability to identify performance indicators and determine actions needed to improve or correct system performance.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret technical instructions in mathematical or diagram form and work with abstract and concrete variables.
• Mathematical skills, including the ability to calculate discounts, interest, commissions, proportions, percentages, area, circumference, and volume, and apply basic algebra and geometry.
• Ability to work with mathematical concepts such as probability and statistical inference.
• Internal audit experience.
• Ability and willingness to adhere to corporate personnel policies and practices, including attendance and punctuality requirements.
• Ability to use basic office equipment such as computers, copiers, scanners, fax machines, and telephone systems.
• Valid driver’s license with a satisfactory driving record.

Additional Skills & Qualifications

• Familiarity with FDA Quality Systems Regulations and broader regulatory affairs principles for medical devices.
• Experience working with ISO-based quality management systems, including ISO 13485 and ISO 14971.
• Ability to apply principles of logical and scientific thinking when evaluating regulatory and technical issues.
• Comfort working with probability and statistical inference in the context of regulatory data and submissions.
• Willingness and ability to learn new software programs as needed to support regulatory and quality activities.
• Strong attention to detail and accuracy in documentation and data review.
• Ability to work effectively in a team environment and collaborate with cross-functional stakeholders.
• Strong organizational skills and the ability to manage multiple projects and deadlines.
• Commitment to continuous improvement in regulatory and quality processes.

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

The pay range for this position is $38.00 - $55.00/hr.

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)

This is a fully onsite position in Davis,CA.

This position is anticipated to close on Apr 25, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $38 - $55