Remote Staff Quality Specialist - Regulatory Compliance

Summary

Join us at iRhythm Technologies, a leading digital healthcare company, as we seek an experienced Staff Quality Specialist - Regulatory Compliance to ensure compliance with quality systems and regulations.

Requirements

• Bachelor’s Degree or equivalent quality/regulatory experience with medical devices
• Must have deep understanding of medical device Quality Management Systems and associated regulatory requirements
• Previous experience in a medical device manufacturing setting with working knowledge of ISO 13485, 21 CFR 820 and ISO 14971
• Strong investigational and problem-solving skills
• Must build rapport across functional teams within the organization
• Attention to detail and timeliness are critical
• Excellent communication (verbal and written) and interpersonal skills required

Responsibilities

• Ensure iRhythm’s site activities comply with iRhythm’s Quality System and applicable international standards / regulations
• Build cross-functional partnerships to proactively align processes and systems at iRhythm’s sites
• Lead site quality awareness and audit readiness activities to maintain a state of “always audit ready” at iRhythm sites
• Maintain a positive working relationship with iRhythm’s Notified Body
• Lead and/or support activities related to external audits by FDA, Notified Body, customers, and other international auditing bodies
• Support the initiation, execution, and closure of field actions and/or recalls
• Support Operations Quality by performing site walkthroughs, Gemba walks, and other proactive compliance activities
• Initiate, execute and/or support Quality Plans related to changes affecting the site

Benefits

• Medical, dental, and vision insurances
• Health savings account employer contributions
• Cafeteria plan pre-taxed benefits (FSA, dependent care FSA, commute reimbursement accounts)
• Travel reimbursement for medical care
• Noncontributory basic life insurance & short/ long term disability
• Emotional health support for you and your loved ones
• Legal / financial / identity theft/ pet and child referral assistance
• Paid parental leave, paid holidays, travel assistance for personal trips and PTO!
• 401(k) (with company match)
• Employee Stock Purchase Plan
• Pet insurance discount
• Unlimited amount of Linked In Learning classes