REMOTE Sr Biomedical Engineer

Job Summary: Develop and author robust documentation for medical devices, focusing on sterilization package labeling, to meet audit requirements and regulatory standards.

Job Requirements:

• 4 years of experience in writing documents specifically for auditors regarding sterilization package labeling.

• Experience in authoring CAPAs (Corrective and Preventive Actions).

• Strong technical writing background with a focus on concise and precise documentation.

Preferred Skills:

• Familiarity with post-market documents and regulatory change impact assessments.

• Ability to write clear, concise, and robust documentation that meets regulatory standards.

• Experience with sterilization packaging, labeling, and related regulatory requirements.

Job Responsibilities:

• Write and develop documentation around standards and regulations for submission to auditors.

• Collaborate with the Neuro Standards Team and Subject Matter Experts (SMEs) to create and approve necessary documents.

• Manage a backlog of documents, ensuring timely completion and meeting monthly approval goals.

• Participate in initiative meetings and work closely with teams focused on sterilization, packaging, labeling, radio regulatory, and risk management.

• Ensure all documentation aligns with regulatory standards and helps prevent issues during audits.

• Focus on writing documentation that supports regulatory compliance for released medical device products.

Pay: 29-39

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

Pay Details: $29.00 to $39.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.