Job Location : Deerfield,IL, USA
About This Role
iRhythm is currently seeking an experienced & motivated Staff Quality Specialist - Regulatory Compliance based remotely. Our work environment is fast-paced, with a collaborative atmosphere. Most of all, we are passionate about delivering innovations that improve the quality of health care and the patient experience. We are looking for like-minded individuals to join our team today!
Specific job responsibilities include:
* Ensure iRhythm's site activities comply with iRhythm's Quality System and applicable international standards / regulations, including ISO 13485, 21 CFR 820, ISO 14971 and EU MDR requirements
* Build cross-functional partnerships (examples: Quality, Regulatory, Operations, and Product Development) 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. This will include pre-audit logistics and requests, front and/or back room support during audits, and coordination of audit responses.
* 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
* Other duties as assigned by the Director, Regulatory Compliance
This role may require up to 20% travel.
About you:
You are a passionate quality or regulatory compliance professional with at least 8 years of experience in a Quality or Regulatory related role.
* 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
* Direct exposure to regulatory body inspections and/or Notified Body audits
* Prior experience managing medical device recalls is a plus
* Prior experience with product recall execution is a plus
What's In It For You
This is a regular full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurances (all of which start on your first day), health savings account employer contributions (when enrolled in high deductible medical plan), 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. Additionally, we offer:
* 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!
iRhythm also provides additional benefits including 401(k) (with company match), an Employee Stock Purchase Plan, pet insurance discount, unlimited amount of Linked In Learning classes and so much more!
FLSA Status: Exempt
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