Job description

Global Compliance Officer
Pay rate: $45.00/hr - $50.00/hr
Hours: 8am-5pm
Location Hebron, KY Must be on-site
Temp to hire - possibly direct

SUMMARY:
The Compliance Officer is responsible for ensuring the client QMS operations meet applicable FDA, EU, Pharmaceutical, Health Canada and other relevant NALA regulations. Complete fluency with not only QMS regulations, but hands-on experience directly working within a state-of-the-art, commercial QMS is required. A working familiarity with UDI and other traceability requirements is also critical for ensuring product traceability is maintained. This role will lead improvements of existing the client QMS elements not excluding GMP (Good Manufacturing Practices) as well as develop new ones as required for new products.
Professional confidentiality is an absolute requirement for this position and is cause for immediate termination if not followed to the highest standard.

RESPO0NSIBILITIES:

• Champion and improve the client CAPA process and be the change leader for the client Quality projects.
• Continually lead and improve traceability systems for on-market products and establish compliant traceability systems for new products.
• Lead & support material compliance with cross functional team.
• Oversee complaint management operations, ensuring appropriate analysis and resolution of customer complaints and associated CAPA.
• Professionally interface with both internal and external stakeholders, including regularly scheduled conference calls and/or onsite, face-to-face visits.
• Champion the need for outside assistance (i.e., consultations) as needed if boundaries are reached.
• Succinctly report findings to senior management both verbally and in writing.
• Support the resolution of regulatory issues for the client’s customers.
• Comprehend and explain complex regulatory requirements to the client stakeholders.
• Collaborate with consultants and legal teams as required to stay abreast of new medical product regulations, assess their impact to the client Vision processes, and outline any essential changes.
• Lead training initiatives, including internal and external communications.
• Ensure risk management processes and records for regulated medical products comply with applicable regulations, not excluding medical devices, cosmetics, drugs, and foods.
• Monitor and submit applicable reports and ensure appropriate responses are sent to competent authorities.

SECONDARY RESPONSIBILITIES:

• Conduct planned / unplanned audits on related compliance topics.
• Directly support regulatory interactions with competent authorities.
• Coordinate with the client-sponsored Subject Matter Experts (SMEs; i.e., key individuals within the client as well as selected consultants and legal teams) to reduce risk exposure and remediate issues in a structured manner.
• Partner with SMEs to ensure development of new products complies with the client QMS requirements.
• Coordinate facility operations with the client senior management to ensure potential breach(es) are appropriately addressed.
• Perform other related duties as needed.

EDUCATION:
Bachelors degree

CERTIFICATIONS:
Training certificates on auditiong and compliance topics, e.g., FDA CFR 820, EU MDR, ISO 9001, ISO 13485, etc
Lead Auditor preferred

EXPERIENCE:
5+ years of experience required
7+ years experience preferred

PREFERRED KNOWLEDGE / SKILLS/ ABILITIES:

• Humility – It is particularly critical this role understands the limits of their knowledge and capabilities, and takes the initiative to notify senior management of the need for SMEs as needed (e.g., external consultants, legal teams) to ensure the client always achieves compliance. Compliance for the client, a global organization, is a large, team effort, and it is more important to achieve that goal than it is to let ego prevent this role from seeking expert help if any regulatory coverage may be lacking.
• Planning and Organizing – Identifies requirements, allocates, and effectively uses information, personnel, time, and other resources necessary for mission accomplishment; establishes appropriate courses of action for self and/or others to accomplish specific goals; develops evaluation criteria and tracking systems for monitoring goal progress and accomplishment; and specifies objectives, schedules, and priorities.
• Decisiveness – Makes decisions, renders judgments, and acts on difficult or unpleasant tasks in a timely fashion, to include the appropriate communication of both negative and positive information and decisions.
• Communication Skill – Presents and expresses ideas and information effectively and concisely in an oral and/or written mode; listens and comprehends what others are saying; shares information with others and facilitates the open exchange of ideas and information; is open, honest, and straightforward with others; provides a complete and timely explanation of issues and decisions in a manner appropriate for the audience; and presents information and material in a manner which gains the agreement of others.
• Interpersonal Skill – Is aware of, responds to, and considers the needs, feelings, and capabilities of others; deals effectively with others in both favorable and unfavorable situations regardless of their status or position; accepts interpersonal and cultural differences; manages conflicts/confrontations/disagreements in a positive manner which minimizes personal impact, to include controlling one’s own feelings and reactions; and provides appropriate support to others.
• Specialty Competence – Understands and appropriately applies procedures, requirements, regulations, and policies; maintains credibility with others on specialty matters; and uses appropriate procedures, or systems in the operational and/or staff environment as the position requires
• Problem Solving and Analytical Ability – Identifies existing and potential problems; notes, understands and includes the critical elements of problem situations; obtains and evaluates relevant information; demonstrates awareness that new and/or additional information sources are required; notes interrelationships among elements; identifies possible causes of the problems; recognizes the need to shift to an alternative course of action including innovative or creative approaches; and appropriately terminates information collection and evaluation activities.
• Self-Development – Accurately evaluates own performance and identifies skills and abilities as targets of training and development activities related to current and future job requirements. Analyzes present career status. Sets goals (short term and/or long term). Identifies resources that are available and methods for self-improvement. Sets realistic time frames for goals and follows up.
• Judgment – Makes well-reasoned and timely decisions based on careful, objective review and informed analysis of available considerations and factors. Supports decisions or recommendations with accurate information or reasoning.
• Direction and Motivation – Sets a good example of how to do the job; demonstrates personal integrity, responsibility, and accountability. Provides advice and assistance to help others accomplish their work. Directs/motivates self. Follow and promote the client Code of Conduct.
• Organizational Knowledge – Demonstrates knowledge of the company’s vision, the mission and the principal programs in the organization.

Benefits (employee contribution):

• Health insurance
• Health savings account
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Life insurance
• Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job Types: Full-time, Contract

Pay: $45.00 - $50.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Compliance Officer: 5 years (Required)
• Auditing: 5 years (Required)
• CAPA: 5 years (Preferred)
• Regulatory reporting: 5 years (Preferred)
• QMS: 5 years (Preferred)
• Medical device: 5 years (Required)

Work Location: In person

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