US Regulatory Affairs Specialist

JOB OVERVIEW:
This position is responsible for acquiring/maintaining/auditing company licensing and product registration. Research and analyze applicable legislation and Federal, State, and Local regulations to ensure the company's ongoing compliance. Provide guidance to Operations and other areas of the company on compliance issues with relation to area of expertise.
KEY RESPONSIBILITIES:
Typically responsible for two or more of the following duties:

• Supporting the pre-acquisition due diligence process for regulatory compliance and quality assurance risk areas by reviewing target company procedures and practices.
• Communicating due diligence findings to Regulatory team leadership to outline target companies' regulatory and quality status and highlight identified risks and remediation proposals.
• Supporting post-acquisition remediation planning and tracking.
• Participating in virtual or onsite regulatory/quality audits of target company facilities as necessary.
• Reviewing post-market surveillance procedures and processes for complaint handling, adverse event reporting, and recalls, to meet FDA and other governmental or auditing agency requirements.
• Evaluating target companies' supplier qualification processes and quality agreements in light of pertinent FDA and ISO 13485 or other quality system requirements or best practices.
• Reviewing target company state and federal licensure status, and supporting the transition of target company licensure in adherence to relevant change of ownership notice requirements.
  

WORK EXPERIENCE:
Typically 2 to 4 years of related professional experience.
PREFERRED EDUCATION:
Bachelor's Degree or global equivalent in related discipline. Typically hold 1 or more industry certifications.
GENERAL SKILLS & COMPETENCIES:

• Professional skills with an understanding of industry practices and company policies and procedures.
• Developing proficiency with tools, systems, and procedures.
• Good planning/ organizational skills and techniques.
• Developing problem-solving skills.
• Good writing and communication skills.
• Excellent conflict resolution skills.
• Good decision-making skills
• Excellent interpersonal skills.
• Exercise judgment within defined procedures and practices to determine appropriate action.
• Direction from manager/director is needed on some issues.

SPECIFIC KNOWLEDGE & SKILLS:

• Thorough understanding of regulations applicable to HS operations
• General Knowledge of ISO 13485
• Quality auditing experience preferred.

The posted range for this position is $54,000-$94,500 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, Flexible Time Off, 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