US Regulatory Affairs Specialist

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.

SPECIFIC KNOWLEDGE & SKILLS: 

• 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

GENERAL SKILLS & COMPETENCIES: 

• 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

MINIMUM WORK EXPERIENCE: 

Typically 2 to 4 or more years of increasing responsibility in terms of any applicable professional experience.

PREFERRED EDUCATION: 

Typically a Bachelor's Degree or global equivalent in related discipline.

TRAVEL / PHYSICAL DEMANDS:

Travel typically less than 10%. Office environment. No special physical demands required.

The posted range for this position is $61,812-$84,992, which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including prior experience, current skills, location/labor market, internal equity, etc.

This position is eligible for a [bonus/incentive] not reflected in the posted range.

Other benefits available include: Medical, Dental and Vision Coverage, 401K Plan with Company Match, PTO, Paid Parental Leave, Income Protection, Work Life Assistance Program, Flexible Spending Accounts, Educational Benefits, Worldwide Scholarship Program and Volunteer Opportunities.

Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status. 

For more information about career opportunities at Henry Schein, please visit our website at: www.henryschein.com/careers

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