Regulatory Affairs Associate

This is a fully remote position, open to applicants in Oklahoma.

📋 Description

• Prepare regulatory documents for in-vitro diagnostic (IVD) submissions to both domestic and international regulatory authorities.

• Provide operational assistance for activities related to regulatory submissions.

• Engage with regulatory agencies to facilitate product registration processes.

• Review shipping restrictions associated with the regulatory status of products.

• Collaborate with Sales and Customer Service teams to ensure adherence to compliance standards.

• Monitor both new and existing regulations that impact IMMY products and processes.

• Standardize regulatory operations and create documented protocols.

• Maintain an up-to-date understanding of submission requirements and procedures across various jurisdictions.

• Prepare and manage technical documentation for products.

• Clarify regulations, procedures, and policies to employees and stakeholders.

• Organize and maintain data and files for future regulatory audits.

• Assist in the review of labeling, promotional materials, legal, and technical documentation for compliance purposes.

⛳️ Requirements

• A Bachelor’s degree in a relevant field or a combination of education and job-related experience.

• A minimum of 2 years of experience in Regulatory Affairs is required for Specialist classification.

• Strong technical writing and verbal communication skills.

• Excellent organizational skills and attention to detail.

• Ability to manage multiple tasks effectively.

• Capability to thrive in a fast-paced, deadline-oriented environment.

• Ability to work independently as well as collaboratively within a team.

• Proficient in organizing information for both internal and external reviews.

• Skill in identifying opportunities to enhance or simplify processes.

• Knowledge of FDA, IVDD, IVDR, ISO 13485, GMP, and other significant international regulatory requirements.

• Competence in reading and interpreting domestic and international IVD regulations.

• Experience in a regulated setting, preferably within Medical Devices or IVDs.

• Familiarity with regulatory submissions, ideally concerning Medical Devices or IVDs.

• Candidates must reside within the United States.

🏝️ Benefits

• Equal employment opportunity and protections against discrimination.

• Background checks conducted in accordance with EEOC, FCRA, and relevant federal, state, and local laws.