A Regulatory Affairs Specialist maintains specialized knowledge of state and federal government regulations that affect an employer. Interprets regulations and implements procedures that bring an employer into compliance with regulations; may audit internal compliance with regulations.
$32-$36 per hour, based on experience and qualifications
Employment Type:
Temporary-to-Hire A growing biotechnology company in Tustin is seeking a Regulatory Affairs Associate to join its team. This is an excellent opportunity for someone looking to begin or build a career in regulatory affairs within the biotechnology and medical device industry. The ideal candidate will be detail-oriented, organized, curious, and comfortable learning new regulatory requirements. This position will provide hands-on exposure to regulatory documentation, product registrations, compliance activities, and coordination with internal teams and external regulatory organizations. What You'll Do Assist with maintaining U.S. and international product registrations, company registrations, and medical device listings. Help prepare, update, and organize regulatory files and technical documentation associated with
IVDD/IVDR
requirements. Provide support for FDA submissions and regulatory filings with other applicable agencies, including 510(k) submissions when needed. Research regulations, industry standards, and regulatory guidance and provide clear summaries and findings to the Regulatory Affairs team. Assist in developing, reviewing, and updating SOPs, work instructions, and regulatory policies. Partner with departments throughout the organization to determine whether proposed product or process changes require regulatory notification, documentation, or approval. Review product labels, marketing content, and other external communications for potential regulatory concerns under the direction of experienced Regulatory Affairs personnel. Help assess products and projects against applicable regulatory requirements and internal compliance standards. Assist with preparation for and participation in regulatory and quality audits, including notified body audits, ISO audits, government inspections, and customer audits. Maintain accurate regulatory records and documentation while helping ensure projects remain organized and on schedule. Provide general support on Regulatory Affairs projects for the company and affiliated organizations as business priorities evolve. Take on additional regulatory and compliance-related assignments as needed. What We're Looking For Bachelor's degree in Biology, Chemistry, Biomedical Sciences, or another related scientific field is preferred. Recent graduates and candidates at the beginning of their careers are encouraged to apply. Previous Regulatory Affairs experience is not required ; a strong interest in pursuing Regulatory Affairs as a career is important. Excellent organizational skills and a high level of attention to detail. Strong written and verbal communication skills. Comfortable researching unfamiliar topics and gathering information from regulations, standards, and other technical resources. Able to evaluate information thoughtfully and ask questions when additional guidance is needed. Strong time-management skills with the ability to manage multiple assignments and competing priorities. Positive, dependable, and collaborative approach to working with others. Self-motivated and willing to take ownership of assignments while knowing when to seek direction. Adaptable and comfortable working in an environment where responsibilities may change based on business needs. Proficiency with Microsoft Office applications and the ability to organize information for reports, presentations, and regulatory documentation. Ability to handle confidential and sensitive information with discretion and professionalism. Why Consider This Opportunity? This position offers an opportunity to gain practical experience across multiple areas of Regulatory Affairs while working alongside experienced professionals. It is particularly well suited for a candidate who wants to develop a long-term career in regulatory compliance within the biotechnology or medical device industry.
Pre-Employment Requirements:
Candidates selected for hire will be required to successfully complete a background check and drug screening prior to beginning employment.
