Governance Risk & Compliance Manager implementing risk management strategies at Sword. Overseeing compliance and security governance practices within the organisation.
About the role
- Regulatory Reporting Specialist responsible for compliance with medical device regulations and reporting practices. Collaborates with cross-functional teams to manage adverse event reporting.
Responsibilities
- Responsible for ensuring compliance with FDA, European, and global requirements governing adverse event reporting
- Assess the reportability status of incoming complaints associated with hip, knee, limb salvage, and robotic devices
- Manage adverse event reporting activities
- Collaborate with several post-market teams and support continuous improvement and efficiency projects
- Review reports of customer complaints and assess them for MDR / MIR reportability
- Ensure initial and follow up reports are submitted to Regulatory Agencies within required timelines
- Partner with Quality Complaint-Handling personnel to assure the complaint records contain all required information
- Support interactions with Regulatory Agencies as required
- Review and analyze data for trending purposes
- Track metrics on process timeliness and effectiveness
- Participate in Post-Market Compliance initiatives
Requirements
- Bachelor’s degree (B.S. or B.A.), preferably in Science, Engineering or related field
- 0–2 years of experience as a regulatory or quality professional in a regulated manufacturing environment
- Ability to manage multiple tasks and meet deadlines
- Experience with post-market MDR/MIR reporting
- Applied knowledge of US and International Medical Device Regulations and Standards including but not limited to: FDA: CFR 21 Part 803 (MDR), and CFR 21 Part 820 (QSR), MEDDEV 2.12-1 (Guidelines on Medical Device Vigilance System), ISO 13485 (International Organization for Standardization)
- Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development and Marketing and Quality.
- Knowledge of manufacturing processes and demonstrated ability to advocate product excellence and quality.
Benefits
- Health insurance
- 401(k) matching
- Flexible work arrangements
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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