Medical Device Document Control Specialist

1 day ago

Agoura Hills, United States Actalent Full time

Job Title: Medical Device Document Control Specialist About Us: Our client is a leading medical device company dedicated to developing innovative and life-saving products. We are committed to quality, compliance, and continuous improvement. Join our team and contribute to our mission of improving patient outcomes and healthcare standards. Job Description: We are seeking a detail-oriented and organized Medical Device Document Control Specialist to join our team. The ideal candidate will be responsible for managing and maintaining all documentation related to our medical devices, ensuring compliance with regulatory requirements and company standards. Key Responsibilities: Manage and maintain document control systems for medical device documentation. Ensure all documents are accurate, up-to-date, and compliant with regulatory requirements (e.g., FDA, ISO 13485). Coordinate the review, approval, and distribution of documents. Maintain records of document revisions, approvals, and distribution. Assist in the preparation and submission of regulatory filings. Collaborate with cross-functional teams to ensure documentation accuracy and completeness. Conduct regular audits of document control processes and systems. Provide training and support to staff on document control procedures. Qualifications: Bachelor's degree in a related field (e.g., Life Sciences, Engineering, Quality Management). Previous experience in document control within the medical device industry. Knowledge of regulatory requirements for medical devices (e.g., FDA, ISO 13485). Strong attention to detail and organizational skills. Excellent communication and teamwork abilities. Proficiency in document management software and Microsoft Office Suite. Pay and Benefits The pay range for this position is $30.00 - $30.00 Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Agoura Hills,CA. Application Deadline This position will be accepting applications until Jan 11, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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