Regulatory Affairs Specialist 3 - Medical Device IVD

Yoh is hiring a Regulatory Affairs Specialist III for our client in San Diego, CA. In this role, you will be responsible for ensuring global regulatory compliance and supporting market access for in vitro diagnostic (IVD) products throughout the product lifecycle. The Regulatory Affairs Specialist III will develop and execute regulatory strategies, prepare complex regulatory submissions, collaborate with cross-functional teams, and serve as a regulatory subject matter expert to support new product development and post-market activities. This role requires strong technical expertise, regulatory knowledge, and the ability to influence stakeholders while ensuring compliance with FDA, EU, and international regulatory requirements.

Industry: Biotechnology 
Location: San Diego, CA
Compensation: $105,800 to $132,250 
Type: Direct Hire

Job Functions

• Prepare and submit complex pre-market and post-market regulatory submissions to the U.S. FDA, EU Notified Bodies, and other international regulatory agencies.
• Develop and execute global regulatory strategies to support new product development and lifecycle management of IVD products.
• Track regulatory submissions, agency correspondence, and regulatory commitments while preparing responses to health authority questions within established timelines.
• Serve as the primary regulatory liaison with health authorities and proactively manage regulatory communications.
• Provide regulatory guidance to cross-functional product development teams from product concept through commercialization.
• Collaborate with subject matter experts to ensure scientific and technical documentation meets regulatory submission requirements.
• Partner with international affiliates and regulatory representatives to coordinate submissions in global markets.
• Assess regulatory impact of product changes and document regulatory assessments within established change control systems.
• Review and approve quality management system documentation, validation reports, technical reports, and related documentation for regulatory compliance.
• Research evolving global regulations and industry guidance to assess business impact, identify regulatory risks, and implement mitigation strategies.
• Prepare regulatory documentation in support of internal audits, regulatory inspections, and agency requests.
• Identify and implement process improvements that enhance regulatory operations and compliance.
• Provide mentorship, training, and technical guidance to junior Regulatory Affairs team members.
• Influence cross-functional stakeholders by providing regulatory expertise and recommendations that support business objectives.
• Provide regular project status updates to management and perform additional duties as assigned.

Education, Licensure and/or Experience

• Bachelor's degree in Life Sciences, Engineering, or a related scientific discipline required.
• Minimum of six (6) years of experience in a regulated industry.
• Minimum of four (4) years of direct Regulatory Affairs experience.
• Prior experience supporting In Vitro Diagnostics (IVD) or Drug/Biologics products is required.
• Demonstrated experience preparing FDA, EU, and international regulatory submissions for medical devices or IVD products.
• Strong knowledge of FDA regulations, international regulatory requirements, and quality management systems.
• Experience supporting product development throughout the entire product lifecycle, from concept through commercialization.
• Strong technical writing skills with the ability to translate scientific information into regulatory documentation.
• Experience assessing regulatory impact of product changes and supporting change control processes.
• Knowledge of IVD reagent chemistry, laboratory automation, software components of medical devices, and applicable regulatory requirements preferred.
• Experience communicating directly with FDA and international regulatory agencies.
• Proficiency with Microsoft Office Suite, Adobe Acrobat, Excel, and document management/change control systems such as LSQM, SAP, and JIRA.
• Excellent analytical, problem-solving, organizational, and project management skills.
• Demonstrated ability to manage multiple complex projects while meeting aggressive timelines.
• Strong written, verbal, and presentation skills with the ability to communicate complex regulatory concepts to technical and non-technical audiences.
• Proven ability to work independently while collaborating effectively within cross-functional teams.

Physical Job Requirements

• Office and laboratory environment.
• Regular use of a computer, keyboard, mouse, telephone, and other standard office equipment.
• Prolonged periods of sitting while reviewing technical documentation and preparing regulatory submissions.
• Occasionally required to stand, walk, reach, bend, and lift up to 20 pounds.
• Must possess visual acuity sufficient to review scientific data, regulatory documentation, and technical reports.
• May require occasional travel to support audits, regulatory inspections, or business meetings.

Estimated Min Rate: $92575.00
Estimated Max Rate: $132250.00


What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

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