Job Description

Regulatory Affairs Specialist – Clinical Laboratories

Location: Onsite – Rochester, NY

Schedule: Monday–Friday, 8:00 AM – 5:00 PM Eastern Time

Pay: $48 - $52 per hour

Assignment Type: Temporary

Overview:

Eastridge Workforce Solutions is seeking a Regulatory Affairs Specialist to support one of our top partners in the medical diagnostics and laboratory industry. This role will support regulatory operations for Clinical Laboratories, focusing on both product lifecycle management and product development initiatives. This is an onsite role located in Rochester, NY.

Key Responsibilities:

• Contribute to the development and implementation of regulatory strategies for both existing and new products.
• Coordinate and manage regulatory applications and submissions in accordance with U.S. and international regulations.
• Evaluate the regulatory impact of products and processes and ensure ongoing compliance.
• Collaborate with cross-functional internal stakeholders and external partners to support regulatory requirements.
• Maintain documentation and support additional regulatory activities as assigned.

Key Stakeholders:

Internal Teams:

• Site Operations
• Regulatory QRC and International
• Business Development
• R&D
• Marketing & Communications

External:

• Vendors (e.g., MPA support)
• Regulatory Agencies

Required Qualifications:

• Bachelor’s degree in a scientific discipline.
• Experience with FDA-regulated medical devices.
• Ability to develop and execute regulatory strategies for complex 510(k) products.
• Knowledge of U.S., EU, and international regulatory standards for IVDs and medical devices.
• Excellent verbal/written communication, organization, and prioritization skills.

Preferred Qualifications:

• Experience with Class II IVD assays and labeling review.
• Familiarity with eSTAR submissions and structured product labeling.
• Experience reviewing marketing and promotional materials for regulatory compliance.
• Advanced word processing and documentation skills.

Work Environment:

• Professional office setting with access to shared printing, archiving, and meeting facilities.
• Standard temperature-controlled climate with moderate office noise.
• Occasional lifting of office supplies (10–15 lbs).
• Regular typing and computer work, with frequent verbal and written communication.

Core Behaviors:

• Thrive Together: Collaborate intentionally and grow as a team.
• Make It Happen: Embrace a results-driven mindset with continuous improvement.
• Commit to Service: Foster a service-first mentality.
• Embrace Inclusion: Be open, authentic, and value diverse perspectives.

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Benefits : Use this link bit.ly/4cGUQSh to learn more about benefits available to Eastridge’s temporary employees. From time to time Eastridge’s clients may offer additional benefits to Eastridge employees while on assignment. Information about those benefits will be communicated when applicable.

Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.

Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.

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