Regulatory Affairs Specialist at iRhythm

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iRhythm

(40 open jobs)

iRhythm Technologies is redefining the standard for ambulatory cardiac monitoring.


Job title
Regulatory Affairs Specialist
Job listing last updated at
Feb 11, 2021
Job listing location
San Francisco
Job listing source
greenhouse
Job listing link
External link
Bay Area company location: 650 Townsend St # 500, San Francisco CA

Job description

About iRhythm:

iRhythm is a leading digital healthcare company focused on the way cardiac arrhythmias are clinically diagnosed by combining our wearable biosensing technology with powerful cloud-based data analytics and machine- learning capabilities. Our goal is to be the leading provider of first-line ambulatory ECG monitoring for patients at risk for arrhythmias. iRhythm’s continuous ambulatory monitoring has already put over 2 million patients and their doctors on a shorter path to what they both need – answers.

About this role:

iRhythm’s Quality Assurance & Regulatory Affairs team is looking for a strong candidate to fill the role as an Regulatory Affairs Specialist. This position provides an opportunity to be at the forefront of medical wearable technologies that is making a difference with patient outcomes and better healthcare, as well as an opportunity for growth into the dynamic field of medical device regulatory affairs.

About you:

As a Regulatory Affairs Specialist with a fast growing, global, Class II/IIa medical device company, you will be responsible for working with cross-functional teams to support regulatory license/registrations for commercialized devices under the direction of senior RA personnel. You will independently organize and maintain device regulatory information and documentation to ensure consistency and regulatory compliance.

Responsibilities:

  • Conducts 510(k) and CE Mark impact assessments for product changes.
  • Co-authors 510(k) submissions and significant change notifications for product changes with moderate business impact.
  • Maintains letter-to-file history and updates technical documentation as needed in support of product changes/life cycle management and post-market data.
  • Monitors and coordinates maintenance of global product registrations, product regulatory certificates, business licenses (e.g. CDPH), and establishment registrations.
  • Maintains regulatory databases such as FURLS, GUDID and EUDAMED to ensure data accuracy.
  • Ensures service continuity with key 3rd party regulatory services (e.g. contract regulatory representatives, standards maintenance service, etc.)
  • Monitors product shipment eligibility based on market clearance/approvals as communicated by senior RA personnel.
  • Coordinates notaries, legalizations, and apostilles in support of product registrations as needed.
  • Serves as the department archivist following document retention guidelines for key RA documentation.
  • Helps identify opportunities and implement process efficiencies.
  • Supports interdepartmental information requests.
  • Performs other regulatory-related duties as assigned.

Qualifications:

  • BA or BS degree required; science, technology, engineering and technology background highly preferred.
  • Minimum 2 years of previous experience working in a regulated industry required; experience in the medical device field highly preferred.
  • Minimum 1 year of regulatory affairs or regulatory compliance experience required.
  • Familiarity with medical device regulations and standards (e.g. 21 CFR 820.30, ISO 13485, IEC 62304, ISO 14971, ISO 10993, etc.) preferred.
  • Strong attention to detail, interpersonal skills, reading comprehension, organizational skills, multi-tasking, and critical thinking/problem-solving skills required.
  • Experience with MS Word, MS Excel, and Adobe PDF to compile and publish documents required.
  • Strong written and oral communication skills.

What’s in it for you:

This is a full-time position with competitive salary package and excellent benefits including medical, dental and vision insurance, paid holidays and paid time off.

iRhythm also provides additional benefits including 401K (w/ company match), an Employee Stock Purchase Plan, annual organizational/cultural committee events and more!

FLSA Status: Exempt

As a part of our core values, we ensure a diverse and inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer (M/F/V/D). Pursuant to San Francisco Fair Chance Ordinance, we will consider for employment all qualified applicants with arrest and conviction records.

Make iRhythm your path forward.

 

 

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