Regulatory Specialist

Paramus, NJ               ·             Full time

About the job

Position Summary/ Objectives

The Regulatory Specialist is responsible for preparing regulatory filings and tracking applications for licensing and certification; assisting project teams to obtain global approval for new or modified products; performing impact analysis of regulatory changes and produces status reports. Regulatory Specialist work is generally independent and collaborative in nature; contributes to moderately complex aspects of a project.

Essential Job Functions:

• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents (i.e. FDA, MDR, MDD, ISO, EN etc.).
• Coordinate, support, and author clear and concise regulatory filings for both domestic and international product registrations. Duties include writing, formatting, compiling and maintaining supporting documentation/technical files for new products and product modifications.
• Coordinate, support, and author clear and concise regulatory responses to requests for additional information by regulatory agencies.
• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance requirements, or clarification and follow-up of submissions under review.
• Prepare technical information for specific distributor/customer requests to support global product registration.
• Collaborate effectively with project teams, peers, and customers to identify solutions with regards to regulatory strategies.
• Collaborate effectively with project teams to identify risks and risk mitigation strategies.
• Identify, obtain and maintain relevant guidance documents, international standards, or consensus standards and distribute or make available to appropriate departments.
• Complete Regulatory Status Determinations for assessment of engineering change orders.
• Complete gap analysis to ensure continued compliance with updated regulations and standards and recommend changes to company quality system procedures.
• Write or update procedures or work instructions related to the regulatory department.
• Develop product labeling, including internal and external promotional material and marketing literature, in compliance with applicable regulations.

Position Authorities

• Initiate, recommend, or provide solutions through designated channels.
• Initiate action to correct or prevent the occurrence of any nonconformities relating to product, process and quality system.

Competencies:

• Meaningful Innovation
• Ownership/Accountability
• Pace/Efficiency
• Teamwork/Collaboration
• Integrity/Ethical Practice
• Resilience/Grit

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 50 pounds.

Supervisory Responsibilities:

This position manages projects/programs but does not supervise other employees.

Education, Experience and Certification:

• Ability to follow written and oral instructions with minimum supervision.
• Good communication skills, both verbal and written reports.
• Good organizational ability and strong attention to detail.
• Ability to utilize computer application packages, such as MS Word, Excel, and Adobe.
• Bachelor’s Degree or equivalent with a minimum of 3 years’ experience in Regulatory Affairs.
• Experience in a medical device or science related field is a plus.
• Possess a working knowledge of State and Federal Law
• Familiar with regulatory requirements for medical devices, such as FDA CFR 820, ISO13485, MDD, EU, MDR, CMDR, etc.

Other Duties as Required:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Posted on Oct 20, 2023.

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