Job Description
Compliance Specialist
What are the top 3 things you are looking for in a candidates experience:
- Medical device recall/field corrective action experience, understanding of FDA/international regulations
- Data analysis and reporting for recalls
- Critical thinking and attention to detail, effective communication
What are the top 3 Tasks or Responsibilities in scope for this role:
- Prepare product bounding/scoping, tracking and execution for medical device recalls.
- Collaborate with various departments/teams to gather recall-related information, prepare documentation, maintain records and resolve issues.
- Document/analyze recall data and prepare reports for internal stakeholders and regulatory agencies, in accordance with regulatory requirements.
Education Required: Bachelor's degree (preferred in Life Sciences/Engineering)Years' Experience Required: 2-5 years
Develops, implements, administers and certifies compliance policies, procedures, and practices. Ensures alignment with legal and ethical standards of the organization. Provides compliance advice, investigates complaints and verifies deficiencies are corrected. Develops employee communication and training programs that focus on the elements of a companywide compliance program. Enforces antibribery and anticompetition laws. Analyzes metrics and audits functional compliance program. Maintains current knowledge of laws for financial, advertising and marketing reporting, regulations, and industry guidance that impact the company's compliance program.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.
Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
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