Global Regulatory Affairs Specialist (Hybrid)

Musculoskeletal Transplant Foundation; 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 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)

Job summary

Musculoskeletal Transplant Foundation is seeking a Regulatory Affairs Specialist responsible for ensuring compliance with regulatory requirements in Edison, NJ. The ideal candidate will maintain current knowledge of regulations and assist in documentation for FDA submissions.

This hybrid role requires commuting to NJ and Jessup, PA, offering a salary range of $80,000-$96,000 annually. Responsibilities include reviewing labeling, conducting audits, and participating in project teams.

Benefits include paid time off, medical and dental insurance, a 401K plan with company match, and tuition reimbursement.

Qualifications

• Bachelor's degree in science or a related field required.
• 3 years experience in an FDA regulated field preferred.
• Knowledge of Good Tissue Practices and Good Manufacturing Practices.

Responsibilities

• Maintain knowledge of existing and emerging regulations.
• Provide technical review of reports for regulatory submissions.
• Act as liaison with various regulatory agencies.
• Coordinate documentation for domestic and international submissions.
• Review and approve labeling and finished good specifications.

Skills

Strong communication

Organizational skills

Time management skills

Technical writing

Ability to work on project teams

Proficient in Microsoft Office

Education

Bachelor's degree in science or a related field

Tools

GTPs/GMPs knowledge

Job description

Musculoskeletal Transplant Foundation is seeking a Regulatory Affairs Specialist responsible for ensuring compliance with regulatory requirements in Edison, NJ. The ideal candidate will maintain current knowledge of regulations and assist in documentation for FDA submissions.

This hybrid role requires commuting to NJ and Jessup, PA, offering a salary range of $80,000-$96,000 annually. Responsibilities include reviewing labeling, conducting audits, and participating in project teams.

Benefits include paid time off, medical and dental insurance, a 401K plan with company match, and tuition reimbursement.