Senior Regulatory Affairs Coordinator - Remote / Telecommute

Cynet systems Inc; Irvine (CA); Remote; USD 60,000 - 80,000; Full time

Job summary

A consulting company in California is seeking an individual with expertise in document control systems and change processes. Responsibilities include collaborating on change requests in Windchill and fulfilling other duties as assigned. Candidates should possess strong analytical and interpersonal skills, with a solid understanding of medical device regulations and attention to detail. This role requires working effectively in a team environment.

Qualifications

• Expertise in document control systems is essential.
• Experience with engineering documents like bill of materials is required.
• Solid understanding of change control processes needed.

Responsibilities

• Collaborate on change requests and notifications on Windchill.
• Complete incidental duties as assigned by leadership.

Skills

Document control system expertise

Good documentation practices

Interpersonal skills

Problem-solving skills

Analytical thinking

Attention to detail

Teamwork

Job description

Job Description

Pay Range: $55hr - $58hr

Responsibilities

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

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.