| Regulatory Compliance Specialist at Remote, Remote, USA |
| Email: [email protected] |
| From: Rashika Kashyap, Amber IT Staffing [email protected] Reply to: [email protected] Hello Partner's, i have very urgent position on Regulatory Compliance Specialist Job Title: Regulatory Compliance Specialist Location: Plymouth, MN-onsite Duration: 12 Month Contract Start Date: ASAP Job Description: Relevant Experience (in Yrs): 10+ years of experience & demonstrated proficiency in Regulatory Compliance is preferred with evidence of continued self- development. Work experience in the Medical Device industry Must Have Technical/Functional Skills: Total 10 years of experience in a Regulatory, Quality, Manufacturing or Engineering function in medical device industry Experience supporting Health Authority inspections, Notified Body audits and internal audit program Working knowledge of medical device regulations and standards: 21 CFR Part 820 QSR, ISO 13485, Brazil GMP, Canada Medical Devices Regulations SOR 98-282, Japan's MHLW MO 169, EU MDR. Lead auditor certification from an accredited / recognized organization. Capability to interpret regulatory requirements in the light of current trends and business application. Ability to accomplish objectives in a timely manner with limited or without day-to-day supervision. Strong problem solving and root cause analysis skills. Look for pragmatic solutions that balance risk/benefit for both short- and long-term success. Be open to diverse opinions and ideas. Active listening. Strong computer skills and use of software application(s), including MS Windows, MS Office (Word, Excel, PowerPoint). Certifications as Green Belt/Process Excellence, CMMI Lead Assessor, or other Quality Certifications will be preferred Experience Required: A minimum with 3+ years of related experience in Regulatory for Medical Device industry. Roles & Responsibilities: Supports/leads development of the Regulatory Compliance Strategy Assists on assessments internal or at supplier) to identify any opportunities to reduce compliance risk Responsible for the Integration of the Audit Program procedures, training and system, L. ETQ) Reports on Project Milestones to the Leadership Team Escalates/communicates any risk identified in the project execution, quality and regulatory compliance related risks or opportunities to appropriate management level. Participates in the project meetings as Regulatory Compliance Representative. Reviews/approves any project plans as Regulatory Compliance Representative Supports the internal audit program that ensures quality management systems are operating in compliance; develops and manages audit plans; conducts audits, develops metrics and compiles data on auditing results, issues, trends and corrective actions and presents to senior management Supports/leads readiness activities for audits/inspections by Health Authorities, Notified Bodies or Enterprise Regulatory Compliance. Research emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance to these requirements. Ensures compliance to regulations, standards, and internal policies Develops and deploys regulatory compliance strategies/initiatives aligned with the Q&C and JJRC goals/objectives. Develops and delivers required training as part of those strategies. Supports processes, organizations, and governance to assure that regulatory compliance related requirements and goals/objectives Partners with stakeholders (e.g., Source Quality, Source. Franchise Quality, Quality Systems, Manufacturing, and other business functions) for the identification of quality and regulatory compliance raks and the development of mitigation plans Provides periodic data and analytics to business partners including regulatory compliance data and current global health authority trends that enable the organization to deliver on quality and regulatory compliance commitments. Supports proactive approach to address regulatory trends. Provides support and regulatory compliance advice for new product introductions and other business growth initiatives as needed Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition Responsible for communicating business related issues or opportunities to next management level Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Performs other duties assigned as needed. Keywords: cprogramm information technology microsoft Minnesota Missouri Regulatory Compliance Specialist [email protected] |
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| Thu Aug 08 19:28:00 UTC 2024 |