Specialist I, Regulatory Affairs And Compliance

Job Summary:

The Regulatory Compliance Support Specialist plays a crucial role in our organization, establishing product compliance spreadsheets and maintaining current product compliance information in our operating systems here at Halkey Roberts.

The Regulatory Compliance Specialist works directly with the Senior Specialist, Regulatory Affairs and Compliance to ensure we are implementing the best practices to ensure effective product compliance with optimized efficiency.

Becoming an effective Regulatory Compliance Specialist requires possessing a healthy balance of skills ranging from technical, effective communication and presentation skills that effectively communicate and work across all levels of the organization.

Duties and Responsibilities:

Developing and maintaining regulatory compliance databases for tracking product compliance.

Effectively communicating with the internal / external stakeholders regarding regulatory compliance and sustainability issues.

Support the development of policies, procedures, and guidelines that promote regulatory compliance and sustainability within an organization's operations.

Required Knowledge, Skills and Abilities:

• Preferably prior regulatory compliance experience in a medical device setting
• Demonstrated ability to create, input and analyze data accurately in Excel
• Demonstrated ability to create or edit documents in Microsoft Word
• Excellent communication skills (both verbal and written) in Microsoft Outlook and Teams
• Excellent organizational skills with a strong attention to details

Physical Demands:

The physical demands described here are representative of those necessary for an employee to successfully perform the essential functions of this job. Reasonable accommodation can be made to enable individuals with disabilities to perform the essential functions.

• Frequent: Talk, hear, speak, and use hands and fingers to operate a computer, telephone, keyboard
• Frequent: Specific vision abilities required by this job include close vision requirements due to computer work for full shift
• Constant: Regular, predictable attendance is required
• Frequent: While performing the duties of this job, the employee is required to sit, stand or walk for extended periods.
• Frequent: Ability to wear personal protective equipment that may include some or all: safety glasses, lab coat, safety shoes, gloves, hearing protection, hair/beard covering. No make-up or nail polish permitted.

Work Environment:

The work environment described is representative of what must be met by an employee successfully perform the essential functions of this job.

• The physical environment is indoors on-site in a controlled climate, office and manufacturing setting. Frequent use of protective clothing is required to maintain clean environment.