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Regulatory Compliance Specialist
Gordian | California, Maryland
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Job Description

Position Summary: The Regulatory Compliance Specialist is responsible for management of external agency activities which included inspection readiness, health authority responses and certificate management. This includes assessment of companyactivities to ensure a state of readiness, projects and

other tasks as assigned.

At Fortive, we believe in you. We believe in your potential - your ability to learn, grow, and contribute in meaningful ways. We believe in the power of great people working together to innovate and solve problems no one could solve alone. We build enduring partnerships with our customers and take on their challenges and opportunities as our own.

Major Duties and Responsibilities: The Regulatory Compliance Specialist will collaborate with business partners to ensure departments are prepared to support external agency inspections to minimize business impact. The Regulatory Compliance Specialist also coordinates and supports requests for directed audits received from senior management and other customer/business partner groups.

Specific areas of focus will be:

Inspection Readiness: Coordinate and maintain the external audit readiness program to ensures the quality management systems are operating in compliance; develops and manages plans; conducts walkthroughs and develops and delivers required training. Research emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing readiness to these requirements.

Certificate Management: Coordinate and maintain the process for certificate management. This includes retention, periodic review, posting and responding to request for certificates from internal/external customers.

Health Authority Responses: Coordinates and supports external audit responses received from senior management and other customer/business partner groups.

Audits: Coordinate and data entry of Internal Audit and/or Supplier Audit program to ensure compliance across all departments within the organization.

Plan, execute and follow up on audit activities.

Special Projects and Base Business: Perform special projects as requested. Responsible for communicating business related issues or opportunities to next management level

Performs other duties assigned as needed.

Education: Required Minimum Education or Equivalent High School graduate, required. Associates college degree, or 4-year college degree (Bachelor's Degree)or equivalent experience in a technical or science related field, preferred.

Years of Related Experience: 1 years in medical device or pharmaceutical industry, preferred.

Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations: (Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.)

Regulatory Knowledge: Working Knowledge of 21 CFR Part 820, QSR, ISO 13485, SOR 98282 CMDR (Canada Medical Device Regulations, J-PAL (Japanese), MDD (European) requirements, EU MDR, Brazil GMP and MDSAP audit program.

Teamwork, collaboration and influencing skills; demonstrated initiative and assertiveness; project management skills; strong computer skills and use of software application(s), including MS Windows, MS Office (Word, Excel, PowerPoint); strong written and oral communication skills.

Preferred: CQE and/or CQA, ASQ CQA certification

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