Regulatory Affairs Specialist Job at Sprint Ray, Los Angeles, CA

WVMwZjdUbEdvR2pNY0U0QnVMbnIydEVtN3c9PQ==
  • Sprint Ray
  • Los Angeles, CA

Job Description

Location: On-Site

At SprintRay, we are in a super-charged growth mode and are constantly looking for ways to maintain the quality of our products and processes while growing at a phenomenal pace. To help grow and maintain the regulatory and quality standards, we are seeking a Regulatory Affairs (RA) and Quality Assurance (QA) specialist to provide RA-QA support and leadership to ensure compliance with FDA QSR, ISO 13485, and MDSAP for all SprintRay products as well as implement and maintain the Company's Quality Management System and follow regulatory guidance to ensure standards and requirements are consistently met.

Job Description:

* Provide RA-QA support to ensure compliance with ISO 13485 MDSAP, and FDA QSR for all products

* Implement and maintain the Company's Quality Management System

* Follow regulatory guidance to ensure standards and requirements are consistently met

* Stay up to date with the new regulations for the medical device manufacturing companies

* Helping the RA-QA team in regulatory submissions

Requirements:

* 3+ years of experience in regulatory compliance and QA

* Previous experience in Medical Devices

* Previous experience working in a RA-QA-related function

* Previous experience with implementation of a Quality Management System

* Strong knowledge and understanding of ISO 13485, MDSAP, and FDA QSR compliance

* Understanding Quality Management System

* Knowledge and understanding of regulatory affairs

* Strong knowledge and understanding of ISO 13485, MDSAP, and FDA QSR compliance

* BS in Chemical or Biomedical Engineering or a related field

* Extremely organized and detailed oriented

* Have great time management skills

* Have excellent written and verbal communication skills in English

* Be a team player, as well as being able to work independently

Target Salary Range: $78,000-$142,560

Actual compensation packages consider a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The estimate provided has not been adjusted for all of these factors. At SprintRay, it is not typical for an individual to be hired at or near the top of the range for their role. The total compensation package for a position may also include an annual performance bonus, medical/dental/vision benefits, and/or other applicable compensation.

About SprintRay:

SprintRay is a highly collaborative environment where innovative people have the freedom to satisfy their curiosity by finding creative solutions to hard problems. If you are a relentless problem solver who wants to shape the future of 3D printing, join SprintRay! Together, we can revolutionize the next 100 years of manufacturing and empower future generations of doctors, designers, and makers all over the world.

To All Recruitment Agencies:

Without a written agreement signed by an officer of SprintRay: a) SprintRay does not accept resumes from recruiting agencies, headhunters, or any other party expecting payment in the event SprintRay speaks with or hires a candidate from such submitted resume; b) SprintRay is not responsible for any fees related to unsolicited resumes or related Terms of Service, and c) Unsolicited resumes received will be considered the property of SprintRay and will be processed accordingly.

Job Tags

Similar Jobs

Addiction Recovery Care

Farm Technician Job at Addiction Recovery Care

 ...accountability, respect for the dignity of life, entrepreneurship, and stewardship are key elements of every thing we do! We are hiring a Farm Technician for our growing team! A Farm Technician aids in raising and feeding livestock and growing crops at a farm. On a typical... 

Global Channel Management, Inc.

Data entry Job at Global Channel Management, Inc.

Job Description: Data entry needs 1+ years' experience Data entry requires: M-F/Full-Time; 8-4:30 (30-Minute lunch) Strong attention to detail Medium-Advance level of expertise with Microsoft Excel Proficient with Outlook Familiar with Cloud-based... 

i-Link Solutions Inc

Software Developer Job at i-Link Solutions Inc

Job Title: Software Developer- Senior Task ID: HBITS-05- 13489 Position Duration: 23.3 Months Client: State of NY Agency: Information Technology Services (ITS) Please call (phone number removed) | (phone number removed) | (phone number removed) or email at... 

NeoGenomics

Courier Job at NeoGenomics

 ...empowering our employees. Not only do we provide career coaches internally, but we offer many training opportunities to expand your...  ...World Class Culture!NeoGenomics is looking for a **Logistics Courier for our Aliso Viejo, CA** location who wants to continue to learn... 

Internet Brands

Inside Sales Consultant (Entry-Level) Job at Internet Brands

 ...(SDR) for one of the Nation's largest Healthcare digital marketing companies. iMatrix...  ...client success. This position is an entry level with the opportunity for advancement, equal...  ...and secure new clients. Internet Consultants work closely with Account Executives to...