Regulatory Affairs Specialist

Jobtailor; New Jersey; On-site; USD 85,000 - 120,000; Full time

Job summary

Jobtailor in Edison, NJ area seeks a Regulatory Affairs Specialist to ensure product development aligns with FDA, Health Canada, and GMP standards. The role involves coordinating global submissions, reviewing labeling and specifications, and maintaining current regulatory knowledge.

The candidate will collaborate with cross‑functional teams, prepare documentation, and support audits and recalls as needed, requiring strong communication and writing skills.

Qualifications

• Bachelor's degree in science or 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.
• Must be able to commute to Edison, NJ and Jessup, PA.
• Standard business hours: Mon-Fri, 8:15am to 4:30pm EST.

Responsibilities

• Coordinate, prepare, and review domestic and international submissions to the FDA, Health Canada, and other international regulatory agencies.
• Balance regulatory concerns with marketing objectives, time to market, technology, compliance, and costs.
• Advise project teams on export and labeling requirements, premarket regulatory requirements, and clinical study compliance.
• Provide documentation in response to Good Tissue Practices/Good Manufacturing Practices inquiries.
• Participate in internal and external audits.
• Review and approve labeling, marketing literature, and finished good specifications.

Skills

Regulatory Submissions

FDA Compliance

Good Tissue Practices

Technical Writing

Team Collaboration

Education

Bachelor's degree in science

Tools

Microsoft Office

Job description

• Work with product development and manufacturing management to ensure product development meets applicable regulatory requirements
• Participate as a member of project teams
• Approve labeling, marketing literature, and finished good specifications
• Maintain current knowledge of regulations, standards, and guidance documents and develop organizational procedures
• Technically review data and reports for regulatory submissions
• Liaise with state, local, federal, and international agencies regarding submission strategies, regulatory pathways, testing requirements, and submission follow-up
• Ensure Design Control, Risk Management, and Release to Market activities comply with applicable standards and regulations
• Coordinate, prepare, and review domestic and international submissions to the FDA, Health Canada, and other international regulatory agencies
• Balance regulatory concerns, marketing objectives, time to market, technology, compliance, and costs
• Advise project teams on export and labeling requirements, premarket regulatory requirements, and clinical study compliance
• Provide documentation in response to Good Tissue Practices/Good Manufacturing Practices inquiries
• Participate in internal and external audits
• Review and approve MTF labeling, finished good specifications, and business-partner marketing literature
• Create, review, and update Design History Files and Device Master Records and conduct periodic compliance audits
• Provide technical support during product recalls
• Assist on special projects and perform additional duties as assigned

Requirements

• 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
• Must be able to commute to Edison, NJ and Jessup, PA
• Standard business hours: Monday through Friday, 8:15am to 4:30pm EST

Core Competencies

Demonstrates expertise in regulatory compliance, including FDA and Health Canada submissions, while effectively collaborating with project teams to balance regulatory requirements with marketing objectives. Proficient in technical writing and maintaining compliance documentation, ensuring adherence to Good Tissue Practices and Good Manufacturing Practices.

Highest-signal resume keywords

• Regulatory Submissions
• FDA Compliance
• Good Tissue Practices
• Technical Writing
• Project Team Collaboration

Hard Skills

• Regulatory Compliance
• Technical Review
• Design Control
• Risk Management
• Documentation Management
• Labeling Approval
• Data Analysis
• Compliance Audits
• Submission Strategies
• Device Master Records

Soft Skills

• Strong Communication
• Organizational Skills
• Time Management
• Team Collaboration
• Problem Solving

Industry Keywords

• FDA Regulations
• Health Canada
• Good Manufacturing Practices
• Clinical Study Compliance
• Export Requirements

Tools & Technologies

• Microsoft Office