Regulatory Affairs Specialist jobs in New York

This position is responsible to acquire/maintain/audit 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:

• 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.
• Implement systems and processes needed to ensure compliance with the receipt, storage and distribution of controlled substances, list 1 chemicals and other regulated products; as well as tracking distribution of prescription drugs and medical devices.
• Conduct periodic audits on facilities and customer site visits to assess levels of compliance and risk.
• Support Distribution Center management and designated staff on the actions necessary to maintain regulatory compliance.
• Provide support during government inspections and formulating the appropriate response and corrective actions.
• Provide guidance to the company and subsidiaries to perform actions in order to maintain regulatory compliance for various facilities.
• Develop appropriate awareness and training programs for TSMs consistent with regulatory compliance policies and procedures.
• Conduct routine Regulatory audits of Henry Schein facilities, affiliates and subsidiaries.
• Participate in special projects and performs other duties as required.

WORK EXPERIENCE:

Typically 2 to 4 years of related professional experience. Regulatory knowledge of controlled substances, list 1 chemicals and other regulated products is a strong plus.

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 9000.

TRAVEL/ PHYSICAL DEMANDS:

· Travel typically 10% to 20%.

· Office environment. No special physical demands required.

The posted range for this position is $57,550-$95,445 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 not reflected in the posted range.

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