US Regulatory Affairs Specialist

Henry Schein

18d•$61,812 - $84,992

About The Position

This position is responsible for acquiring and maintaining product registrations for domestic and international markets. Provide direction to the business as necessary regarding applicable U.S. and international regulations. Research and analyze applicable legislation and Federal, State and Local regulations to ensure the company’s ongoing compliance. KEY RESPONSIBILITIES: Research and analyze applicable laws and regulations; develop and implement the necessary policies and procedures to ensure the Company’s ongoing compliance with Federal, State and local requirements. Initiate and maintain medical device product registrations globally, focusing on international markets. Support the development of Regulatory strategies and processes. Works with subsidiary office personnel and distributors to provide direction and assistance in all matters of product legal/regulatory compliance, registrations and availability in domestic/international markets. Ensure only products legally registered are sold into international markets in accordance with U.S. export regulations. Assist in SOP development and review. Provide regulatory input to product lifecycle planning. Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions Determine and communicate submission and approval requirements Participate in risk benefit analysis for regulatory compliance Assess the acceptability of quality, preclinical and clinical documentation for submission filing Compile, prepare, review and submit regulatory submission to authorities Monitor impact of changing regulations on submission strategies Monitor applications under regulatory review Provide support during inspections and formulating the appropriate response and corrective actions Assist compliance with product post marketing approval requirements Review regulatory aspects of contracts Assist with label and Instructions for Use (IFU) development and review for compliance before release Ability to manage multiple establishment and product registration activities Submit and review change controls to determine the level of change and consequent submission requirements Provide regulatory input for product recalls and recall communications Other duties as assigned.

Requirements

2-4 years preferred experience in medical device (U.S. FDA regulated and registered) Manufacturer or Specification Developer in the U.S. and/or Foreign regulatory submissions.
Experience with FDA pre-market submissions preferred.
Experience with ISO 13485 and EU MDR preferred
Good understanding of industry practices
Proficient with tools, systems, and procedures
Basic planning/organizational skills and techniques
Good decision making, analysis and problem solving skills with ability to multi-task
Good verbal and written communication skills
Good presentation and public speaking skills
Good interpersonal skills
Basic conflict resolution skills
Developing professional credibility
Typically 2 to 4 or more years of increasing responsibility in terms of any applicable professional experience.

Responsibilities

Research and analyze applicable laws and regulations; develop and implement the necessary policies and procedures to ensure the Company’s ongoing compliance with Federal, State and local requirements.
Initiate and maintain medical device product registrations globally, focusing on international markets.
Support the development of Regulatory strategies and processes.
Works with subsidiary office personnel and distributors to provide direction and assistance in all matters of product legal/regulatory compliance, registrations and availability in domestic/international markets.
Ensure only products legally registered are sold into international markets in accordance with U.S. export regulations.
Assist in SOP development and review.
Provide regulatory input to product lifecycle planning.
Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
Determine and communicate submission and approval requirements
Participate in risk benefit analysis for regulatory compliance
Assess the acceptability of quality, preclinical and clinical documentation for submission filing
Compile, prepare, review and submit regulatory submission to authorities
Monitor impact of changing regulations on submission strategies
Monitor applications under regulatory review
Provide support during inspections and formulating the appropriate response and corrective actions
Assist compliance with product post marketing approval requirements
Review regulatory aspects of contracts
Assist with label and Instructions for Use (IFU) development and review for compliance before release
Ability to manage multiple establishment and product registration activities
Submit and review change controls to determine the level of change and consequent submission requirements
Provide regulatory input for product recalls and recall communications
Other duties as assigned.