Description

Paragon 28’s growth continues and we’re looking for more great employees! Now is your chance to join this public company dedicated to improving a patient’s quality of life with the treatment of the most challenging foot and ankle conditions! We are currently looking to fill the position of Global Quality Compliance Specialist II - Complaints with a starting range of $46,000 - $85,000/year, dependent upon experience, education, and skills. This role is eligible for remote work within the US.

The Global Quality Compliance Specialist researches and investigates complaints associated with medical device products and initiates/completes medical device regulatory reporting for adverse events. Provides assistance in all areas of complaint handling including supporting adverse event reporting to ensure the complaint(s) is handled in an accurate and timely fashion. This role ensures completeness and consistency of documentation for these post-market activities under limited supervision.

Key Responsibilities

• Act as the primary resource for intake of global complaints and feedback under limited supervision.
• Assess details of an event against procedural requirements to classify the event as a complaint, feedback and/or service incident; proceed accordingly per procedures.
• Perform follow-up actions to obtain additional event information by effectively collaborating cross-functionally, as applicable, with Sales, Marketing, Quality, Engineering, Clinical, and End Users directly; including information made available through internal data sources such as ERP, Complaint handling databases, etc.
• Evaluate complaint details in a timely manner to determine chain of events and conduct accurate assessments of the event to determine reportability.
• Prepare and submit Medical Device Reports and adverse event reports globally on-time per established requirements and provide professional, timely responses to all Regulatory Authority requests pertaining to complaints and/or medical device reports.
• Conduct timely re-assessments of an event when new information has been received to determine if an initial or supplemental MDR or other applicable adverse event report is required per applicable regulations.
• Proper determination for escalation of events to CAPA or Recall when required per documented procedures.
• Provide guidance and support, as directed by Manager, to department Specialists on effective and compliant approaches to complaint investigations and adverse event reporting.
• Create and revise departmental standard operating procedures, work instructions and forms.
• Responsible for completing work activities on-time and in accordance with established requirements.
• Develop and implement long term problem-solving strategies and area improvements.
• Effective communication and collaboration with other Quality Compliance associates, as well as all members of the organization.
• Raise awareness of Complaint related procedures within the organization and assist Quality Management in the identification and resolution of quality issues associated with complaints.
• Analyze departmental data per timeliness requirements; prepare reports and presentations as assigned.
• Other duties as assigned.

Qualifications

• Associate Degree or 5 years relevant Quality experience required.
• 3 years experience in complaint handling and medical device reporting; Domestic and/or International.
• Familiarity with 21 CFR 820, ISO13485, working in a regulatory environment as well as reading/interpreting regulatory requirements and standards.
• Experience in corrective and preventive action and medical device recalls.
• Demonstrableanalytical, interpretative, and problem-solving skills and the ability to learn quickly, adapt and apply new knowledge.
• Familiarity with technical writing, report preparation, data analysis, compiling metrics and presentations.
• Demonstrableanalytical, interpretative, and problem-solving skills and the ability to learn quickly, adapt and apply new knowledge.
• Strong customer service/interpersonal skills to handle phone calls, emails with external customers, internal customers, and suppliers.
• Moderate computer skills (MS Office suite as well as Adobe Acrobat).

P28 is a leader in the development and distribution of medical solutions for the foot and ankle industry. Established in 2010,every member of our inspired and dedicated team serves a vital role in the achievement of our mission: to strategically build a company around the core principles that drive innovation and quality. We're located at 14445 Grasslands Dr., just off E-470 and Peoria St. on the east side of Englewood, CO.

We offer comprehensive medical coverage with generously subsidized premiums for both employees only and coverage with dependents. Plans include prescription drug and behavioral health coverage as well as telemedicine services. Additional options for dental and vision benefits, life and disability coverage, flexible spending accounts, supplemental health protection plans (accident, critical illness), pet insurance and more. Free counseling services and resources are offered for emotional, physical, and financial wellbeing through our Employee Assistance Program. A safe harbor 401(k) Plan with 3% match and an Employee Stock Purchase Plan, which allows purchase of P28 stock at a discounted rate. You are able to accrue 19 days of PTO over 12 months to maintain a fulfilling work/life balance. Our working environment is considered Colorado Casual. Onsite we have a fresh food kiosk, free parking and will have a new, expanded fitness center!

Paragon 28 is an equal opportunity employer and values diversity. All employment decisions are decided on the basis of qualifications, merit and business need.

Notice to Recruiters and Staffing Agencies: to protect the interests of all parties, Paragon 28, Inc. will not accept unsolicited resumes or referrals from any source other than directly from a candidate or an approved vendor that has a written and signed agreement in place through the Paragon 28, Inc. HR department. Please do not contact or forward resumes or referrals to our company employees. Any unsolicited resumes will be considered Paragon 28, Inc. property. Paragon 28, Inc. is not responsible for any charges or fees related to unsolicited resumes or referrals.