The Regulatory Compliance Specialist position is responsible for the day-to-day management of licenses for LSL operation. This position is also responsible for helping to maintain the Quality Management software and assist in other activities as needed, such as revising Standard Operating Procedures, audits, document support, data gathering, metrics, and record review.
Regulatory Compliance Specialist
- Dallas, TX
- IT and Infrastructure Services
- Full Time
- Verify Client,Customer and product licenses in order to receive and ship product.
- Assist with managing and renewing LSL licenses and certifications.
- Be proficient with and assist in maintaining the Quality Management Software, MQ1.
- Author or revise Standard Operating Procedures, Work Instructions, and training modules as assigned.
- Be a part of the internal audit team and assist in external audits, as needed.
- Maintain Quality files as applicable, including review of record and forms to ensure compliance with established LSL procedures and regulations.
- Gather and prepare quality metrics, as required monthly and for Management Review.
- Support and assist all departments with research/investigation to maintain compliance with business and regulatory needs.
- Lead change initiatives by identifying best approach for implementing strategic processes.
- Make suggestions on Quality improvements.
- Perform training on Quality related documents when necessary.
- Other duties as assigned
QUALIFICATIONS AND JOB SPECIFICATIONS
- Bachelor of Science (B.S.) degree (preferred in the scientific disciplines).
- Minimum of 1-3 years of experience in a Quality or Regulatory role in medical device, pharmaceutical or other regulated industry.
- Demonstration of the following: Effective time management skills Impeccable verbal and written communication skills Ability to conduct appropriate research as needed Strong presentation skills Strong analytical skills for safety and compliance Attention to detail and organization Critical thinking Interest to work in a fast-paced environment
- Deftly navigate through Quality and Warehouse Management Systems with training – MQ1, Tecsys Elite, WebCTRL
- Intermediate Microsoft Office skills: Outlook, Excel, PowerPoint
- Knowledge of applicable state and federal laws for warehousing and distribution of pharmaceutical and medical devices as well as the ability to interpret and apply rules and regulations including FDA, DEA, PDMA, DSCSA
- Intermediate public speaking and presentation skills
- Ability to track quality metrics/ trends
- Excellent verbal and written communication skills
ADDITIONAL EMPLOYMENT REQUIREMENTS
- Must be able to successfully pass all preliminary employment requirements (i.e., background check and drug screen).
- Must have a valid driver’s license.
- Work is light to medium in nature with frequent walking to perform assigned tasks.
- Must be able to safely conduct occasional lifting of 20 to 50 lbs.
- Activities occur within a typical office environment.
- 10% of time is spent in a warehouse setting.
- Laptop computer, cell phone, fax machine, copier, and desk phone
- Outlook, Excel, Word, PowerPoint, and MQ1 (Quality Management Software)