**Supplier Regulatory Compliance Specialist**
**Location: Remote**
**Pay Rate: $30/hr. (non-exempt)**
**JOB DESCRIPTION**
**Summary/Objective**
The Supplier Regulatory Compliance Specialist ensures the execution of quality system compliance activities associated with the timely and accurate documentation of supplier audit responses in an electronic database. The Supplier Regulatory Compliance Specialist performs these activities to applicable quality management system standards for Fortune 500 Medical Device Companies. The Supplier Regulatory Compliance Specialist communicates with suppliers globally.
This individual will support in the management and tracking to closure of Suppliers commitments. Supports the completion of Follow Up Reports.
**Responsibilities**
Under supervision and in accordance with all applicable federal, state and local laws/regulations and client procedures and guidelines, this position:
- Performs according to the company's quality policy and corporate rules in all business activities.
- Complies with policies, procedures, company and regulatory requirements.
- Ensures on time completion of training.
- Ensures that related Quality Records are updated in a timely manner.
- Engages with Suppliers to request timely provision of objective evidence
- Reviews documentation for identified Supplier audit observations
- Identify process improvements related to standard operating procedures and systems.
- Primary duty includes the exercise of discretion and independent judgment with respect to matters of significance.
**Other Duties**
Other duties may be assigned as required by BEPC management.
**Competencies**
- Capable of managing many unique records while maintaining focus
- Excellent prioritization skills
- Excellent written and oral communication skills
- Strong collaboration skills to partner effectively both internally and externally
- Ability to make the complex clear and easily understood by others
- Ability to work in a fast-paced changing business environment
- General knowledge of regulatory requirements in the FDA/ISO/Health Authority-regulated industry (medical devices or pharmaceutical), with the ability to relate them to business/quality issues
**Supervisory Responsibility**
This position is an individual contributor position.
**Position Type/Expected Hours of Work**
This is a full-time position, and hours of work typically Monday through Friday, 8:00 a.m. to 5:00 p.m. local time. However, agility and quick response time to customer and employee requests may be required at other times. This position works remotely.
**Travel**
This position requires mínimal to no travel, e.g. < 5% as required to meet customer & business needs.
**Required Education and Experience**
- Bachelor’s degree or equivalent required; concentration in Engineering or technical field preferred
- 1-3 years or more experience in a FDA regulated industry (pharmaceutical or medical devices) or another highly regulated industry is required.
**AAP/EEO Statement**
BEPC Inc. policy is to affirmatively implement equal opportunity for all employees and applicants for employment without regard to race, color, religion, sex, national origin, disability, military status, genetic information, or any other basis prohibited by law. Additionally, BEPC Inc. does not discriminate against an employee or applicant who acts to oppose such discrimination or participates in the investigation of a complaint related to discriminatory employment practice. Employment decisions will be made on the basis of each applicant’s job qualifications, experience, and abilities.
Tipo de puesto: Jornada completa
Horario:
- Turno de 8 horas
Prestaciones:
- Seguro de gastos médicos
- Seguro de la vista
- Seguro dental
- Seguro de vida