Regulatory Specialist Zonare Medical Systems
THIS JOB HAS EXPIRED JOB SUMMARY:
The Regulatory Specialist will maintain and implement the change management system in support of quality systems and practices to meet ZONARE, customer and regulatory requirements. Severs as a quality representative contact on own area of expertise and supports corporate and other business offices.
Specific Duties and Responsibilities:
Provide documentation and change management (ECO) support on a timely and accurate basis. ECO Management includes: (1) Prioritizes requests for urgent ECOs; (2) Communicates issues with ECO originator and approvers; (3) Ensures ECOs are processed in a timely manner; (4) Ensures ECOs comply with ZONARE Document Control Policies and Procedures; (5) Chairs Change Control Board (CCB) meetings; and, (6) Trains new ZONARE employees in use of Document Control System
Maintains company quality system records including Controlled Document Locations, Device History Records, Design History Files, Management Review, Internal Audits, etc. in accordance with ZONARE procedures and policies
Maintains company Periodic Review process for ZONARE?s quality system procedures.
Assists regulatory in compilation and maintenance of regulatory submissions, approval and certificates.
Undertakes specific projects and works on own initiative
Bachelors Degree or equivalent combination of education and experience.
2 - 4 years documentation related experience (medical device related documentation experience preferred)
Individual must be motivated to work independently as well as with teams. He or she must be able to manage multiple tasks and prioritize appropriately. Must be detail oriented with good written, verbal and organizational skills. PC skills including use of Windows Operating systems and MS office applications are required.
Working Conditions (OSHA requirement)
General office environment. Work is generally sedentary in nature, but may require standing and walking for up to 10% of the time. There are no hazardous or unpleasant conditions caused by noise, dust, etc. Work is generally performed within an office environment, with standard office equipment available. . Willing and able to work flexible and/or after hours and weekends, as needed.
||Mountain View, CA |
THIS JOB HAS EXPIRED