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Regulatory Affairs Analyst- St. Paul, MN - St Paul, United States - MGC Diagnostics
Description
Are you looking for an opportunity to grow where your experience matters? Do you strive for a career with meaning and purpose? If you thrive in a fast-paced environment and want to work with a great team, we might be a fit
MGC Diagnostics ) is a leader in providing innovative technology for cardio-respiratory diagnostics. We recognize that our success depends upon the capabilities of our employees to assist MGC Diagnostics in achieving its business goals. MGC Diagnostics is proud of its collaborative environment where it values contributions of each of its team members. We offer competitive benefits and profit sharing.
Position Title: Regulatory Affairs Analyst
Department: Quality Assurance/ Regulatory Affairs
Location: St. Paul, MN (on-site)
PRIMARY PURPOSE
The Regulatory Affairs Analyst will ensure compliance to applicable quality and regulatory requirements. This role manages support of vital regulatory tasks including complaint processing, post-market surveillance, and recall/ adverse event reporting. The Analyst supports regulatory activities across pre- and post-market phases and conducts regulatory gap assessments to mitigate compliance risks.
ORGANIZATIONAL RELATIONSHIPS
Reports to: Manager, Quality Systems
KEY RESPONSIBILITIES AND ESSENTIAL FUNCTIONS
Complaint Processing:
Investigate and document customer complaints to identify quality issues and ensure compliance with applicable regulatory standards.
Collaborate with cross-functional teams to analyze root causes and implement corrective actions to prevent recurrence of issues.
Post-Market Surveillance:
Monitor and analyze post-market data to assess the safety and effectiveness of medical devices throughout their lifecycle.
Prepare and review periodic reports on product performance, identifying trends that may require regulatory action or product improvements.
Recall/ Adverse Event Reporting:
Coordinate the timely reporting of adverse events and potential recalls to regulatory authorities, ensuring compliance with legal obligations.
Evaluate incident reports to determine the necessity for corrective actions and facilitate the execution of recall strategies, if required.
Pre-Market Regulatory Support:
Assist in preparing regulatory submissions for new products or changes to existing products, ensuring all necessary documentation meets regulatory standards.
Conduct thorough reviews of product labeling and marketing materials to guarantee compliance with regulatory requirements before market launch.
Post-Market Regulatory Support:
Provide ongoing regulatory advice and updates to ensure continued compliance of products with international standards and regulations post-launch.
Engage in continuous improvement initiatives by reviewing and updating regulatory strategies and documentation in response to evolving regulatory landscapes.
Regulatory Gap Assessments:
Continuously assess the QMS against global medical device regulations, with a primary focus on the EU Medical Device Regulation (EU MDR).
Identify, report, and mitigate any gaps or non-conformities in the QMS related to global regulations.
Continuous Improvement:
Proactively identify opportunities for process and quality improvements.
Collaborate with cross-functional teams to implement enhancements to the QMS.
Accept other responsibilities as assigned.
Complete training as identified by standard operating procedures and procedural work instructions.
Regular attendance is an essential job function.
Follow all Company policies and procedures relating to confidential propriety information (CPI) including but not limited to what is outlined in the Confidentiality and Non-Solicitation Agreement.
CONTACTS:
INTERNAL: All Departments
EXTERNAL: Suppliers, Customers, External Auditors and Assessors from Notified Body or other regulatory agencies
JOB SPECIFICATIONS:
Must Have – Minimum Requirements
Bachelor's Degree in Technical, Scientific, or Engineering discipline
5-7 years of experience in Quality Assurance, Regulatory Affairs, or other Quality Systems role, preferably in medical device or other regulated industry.
Knowledge of ISO 13485, MDSAP, EU MDR, UK MDR and other global regulatory requirements.
Process-oriented problem solver and strong documentation creation/ management experience.
Nice to Have
Audit Experience (both as auditee and/or auditor)
WORKING CONDITIONS OR PHYSICAL REQUIREMENTS:
Will be required to regularly stand for extended periods of time; use hands and fingers, handle or feel objects, talk, hear, and see. Occasionally lift and/or move up to 50 pounds, stand, walk, climb, balance, stoop, kneel, crouch, or reach with hands and arms. Requires repetitive motion and manual dexterity. The environment is fast paced; time pressured and requires accuracy. Will be required to regularly multi-task between projects, move throughout the office building and effectively communicate. The normal production environment can be louder due to equipment running.
