Regulatory Affairs Coordinator

Sunrise Systems; Irvine (CA); Remote; USD 60,000 - 80,000; Part time

Job summary

A leading medical devices company is seeking a Regulatory Affairs Coordinator for a 3-month remote contract. Responsibilities include collaborating on change requests and ensuring compliance with regulatory standards. Ideal candidates will have expertise in document control systems and strong analytical skills. The hourly compensation ranges from $57 to $59, with benefits including medical coverage and sick time.

Benefits

Medical coverage

Dental insurance

Vision insurance

Sick time benefits

Qualifications

• Proven expertise in using a document control system.
• Solid understanding of good documentation practices and change control process.
• Ability to manage competing priorities in a fast-paced environment.

Responsibilities

• Collaborate and approve change requests/change notifications on Windchill.
• Perform other incidental duties assigned by Leadership.

Skills

Document control system expertise

Good documentation practices

Communication skills

Problem-solving skills

Attention to detail

Job description

Overview

Our client, a leading Medical Devices Manufacturing Company, is looking for a Regulatory Affairs Coordinator – 3. This is an initial 03 Months Contract and Remote role.

Job Title: Regulatory Affairs Coordinator – 3
Job Id: 25-10826
Location: Remote
Duration: 03 Months Contract
Position Type: Hourly Contract Position (W2 only) Remote

Key responsibilities

• Collaborate and approve change requests/change notifications on Windchill
• Other incidental duties assigned by Leadership

Qualifications / Additional skills

• Proven expertise in using a document control system
• Solid understanding of good documentation practices and change control process
• Experience reviewing bill of materials, process sheets, and engineering drawings
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving, organizational, analytical and critical thinking skills
• Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Must be able to work in a team environment, including inter-departmental teams
• Ability to build productive internal/external working relationships

Compensation & Benefits

Compensation: The hourly rate for this position is between $57-$59 per hour. Factors which may affect starting pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate.

Benefits: Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.

Qualified candidates please send your word format updated resume at the earliest to Pavan: [732-395-4444] OR Sangeeth: [732-395-4555]. Thank You.

Sunrise Systems