Regulatory Affairs Specialist- Remote

MTF Biologics; Edison (NJ); Hybrid; USD 80,000 - 96,000; Full time

Benefits offered by this job

4 weeks Paid Time Off (PTO)

Paid holidays

Medical, dental, vision, and prescription drug insurance

401(k) plan with company match

Short and long-term disability

Life and accidental death insurance

Tuition reimbursement

Health Care/Dependent Care Flexible Spending Accounts

Adoption assistance

Voluntary benefits (e.g. pet insurance, legal, home and auto insurance)

Sword Health (at-home physical therapy)

Job summary

MTF Biologics in Edison, NJ is looking for a dedicated professional to handle FDA regulatory compliance and documentation. In this hybrid role, you will maintain current knowledge of regulations, oversee project compliance, and assist teams in regulatory submissions.

A Bachelor’s degree in a science-related field and three years of experience in an FDA-regulated field are required. The position offers a competitive salary of $80,000-$96,000 per year, along with comprehensive benefits.

Qualifications

• Three years of experience in an FDA-regulated field.
• Knowledge of GTPs/GMPs.
• Ability to work on project teams.

Responsibilities

• Maintain knowledge of regulations and develop clear procedures.
• Provide technical reviews for regulatory submissions.
• Act as a liaison for communication with regulatory agencies.
• Participate in project teams to ensure compliance.
• Coordinate documentation for FDA and international submissions.
• Balance regulatory concerns with marketing objectives.
• Advise teams on export and clinical study compliance.
• Provide documentation for Good Tissue Practices.
• Participate in audits.
• Review and approve labeling and specifications.
• Create and audit Design History Files.
• Support during product recalls.
• Assist on special projects as assigned.

Skills

Strong communication

Organizational skills

Time-management skills

Technical writing

Proficient in Microsoft Office

Education

Bachelor's degree in science or a related field

Job description

Overview

MTF Biologics processes tissue grafts from human donors that are used in a growing array of clinical applications – positively affecting lives across the globe. As a global nonprofit organization that saves and heals lives by honoring donated gifts and serving patients, we collaborate with medical, scientific, and organ and tissue donation communities.

Shift: Monday through Friday 8:15am to 4:30pm.
Hybrid position must be able to commute to Edison, NJ and Jessup, PA.
Salary Range: $80,000-$96,000/yr.

Responsibilities

• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. Utilize this understanding to develop clear procedures for the organization.
• Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
• Act as a liaison between the organization and state, local, federal, and international agencies, communicating on pre‑submission strategies, potential regulatory pathways, compliance test requirements, and clarification and follow‑up of submissions under review.
• Participate as a member of project teams to ensure Design Control, Risk Management, and Release to Market activities are in compliance with appropriate standards/regulations.
• Coordinate, prepare, and review documentation for international and domestic submissions to FDA, Health Canada, and other international regulatory agencies.
• Strategically achieve and maintain a balance between regulatory concerns, marketing objectives, time to market, technology, compliance, and costs.
• Advise project teams on export and labeling requirements, pre‑market regulatory requirements, and clinical study compliance issues.
• Provide documentation in response to outside inquiries relating to Good Tissue Practices/Good Manufacturing Practices.
• Participate in internal or external audits.
• Review and approve MTF labeling and finished good specifications, as well as the marketing literature of business partners.
• Create, review, and update Design History Files (DHFs) and Device Master Records (DMRs), and conduct periodic audits to ensure compliance with MTF Design Control procedures.
• Provide technical support during product recalls.
• Assist on special projects and perform additional duties as assigned.

Qualifications

• Bachelor's degree in science or a related field.
• Three years of experience in an FDA‑regulated field.
• Knowledge of GTPs/GMPs.
• Ability to work on project teams.
• Strong communication, organizational, and time‑management skills, including technical writing.
• Proficient in Microsoft Office.

Benefits

• 4 weeks Paid Time Off (PTO)
• Paid holidays
• Medical, dental, vision, and prescription drug insurance
• 401(k) plan with company match
• Short and long‑term disability
• Life and accidental death insurance
• Tuition reimbursement
• Health Care/Dependent Care Flexible Spending Accounts
• Adoption assistance
• Voluntary benefits (e.g., pet insurance, legal, home and auto insurance)
• Sword Health (at‑home physical therapy)