Regulatory Affairs Specialist- Remote

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 their organization and state, local, federal, and international agencies, including communicating on pre-submission strategies, potential regulatory pathways, compliance test requirements, or 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.
• Cook up documentation for international and domestic submissions for 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 various subjects, including export and labeling requirements, premarket regulatory requirements, and clinical study compliance issues.
• Create, review, and update Design History Files (DHFs) and Device Master Records (DMRs) as well as conduct periodic audits of the files and documents to ensure compliance with MTF Design Control procedures.
• Provide technical support during product recalls.
• Afford assistance on special projects and perform additional duties as assigned.

Qualifications

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

Benefits

• 4 weeks Paid Time Off (PTO)
• Paid Holidays
• Medical, Dental, Vision Insurance and Prescription Drug Insurance
• 401K plan with company match
• Short & Long Term Disability
• Life & 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)