Regulatory Affairs Specialist

Musculoskeletal Transplant Foundation

Edison (NJ)

Hybrid

USD 80,000 - 96,000

Full time

14 days+

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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

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 the medical, scientific, as well as organ and tissue donation communities.

Our goal is simple–do what's right for patients, surgeons, tissue donors, and their families through our guiding principles.

The Regulatory Affairs Specialist is responsible for working with product development and manufacturing management to ensure that the product development process meets all applicable regulatory requirements. Participate as a member of project teams. Responsible for the approval of labeling, marketing literature and finished good specifications.

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 their organization and state, local, federal, and international agencies. Including communicate 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
Coordinate, prepare and review documentation for international and domestic submissions for 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.
Responsible for advising project teams on various subjects, including export and labeling requirements, premarket regulatory requirements, and clinical study compliance issues.
Provide documentation in response to outside inquires 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 our business partners.
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
Assist 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 Information

At MTF Biologics we provide comprehensive benefits and resources to support our employees physical, emotional, and financial health.