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File Manager

Company: SunMed
Location: Grand Rapids
Posted on: April 10, 2021

Job Description:

The Technical File Manager is responsible for establishing and sustaining Technical Files and related technical documentation. This position will ensure that Technical Files and related documentation is revised as product changes are planned and executed. They will coordinate efforts associated with the preparation of regulatory documents and submissions (i.e. Tech File audits, 510(k) submissions). This position communicates with regulatory agencies regarding submission strategies, potential regulatory pathways, and compliance test requirements. The Technical File Manager will represent SunMed Technical Files during internal and external audits. Likewise, this position will work with customers on technical documentation requests.The Technical File Manager must identify evolving and relevant guidance, standards, and requirements and implement them in the Technical File process.
Position QualificationsThe specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance. These competencies are generally demonstrated through specific service, education, or training.
Knowledge: Acquired through education, certifications, training, experience.

  • Knowledge of quality standards and regulations for medical devices (e.g. ISO 13485, FDA QSR, EU Medical Device Directives and EU Medical Device Regulations, and Canadian Medical Device Regulations). Skills & Abilities:
    • Excellent technical writing skills.
    • Excellent verbal and written communication skills.
    • Excellent organizational skills and attention to detail.
    • Ability to multi-task.
    • Excellent critical thinking, using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
    • Active learning - understanding the implications of new information for both current and future problem solving and decision making.
    • Excellent time management.
    • Strong computer skills: MS Word, MS Excel (chart, pivot tables), PowerPoint, and database management.
      Level of Experience:
      • A minimum of 5 years of Quality and/or Regulatory experience in an FDA regulated and/or ISO certified facility (preferably ISO 13485).
        Level of Education:Bachelor degree or equivalent work experience.
        Travel:Occasional overnight travelUp to 10%
        Essential Duties and ResponsibilitiesThe core tasks, duties, and responsibilities that must be performed on the job.
        • The Technical File Manager is responsible for establishing and sustaining Technical Files and related technical documentation. Compile and maintain regulatory documentation, databases, and systems.
        • Coordinate efforts associated with the preparation of regulatory documents and submissions (i.e. Tech File audits, 510(k) submissions).
        • Develop and conduct regulatory training related to technical documentation.
        • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
        • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
        • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
        • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
        • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
        • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
        • Participate in internal and external audits.
        • Prepare or maintain technical files as necessary to obtain and sustain product approval.
        • Recommend changes to technical documentation procedures in response to changes in regulations or standards.
        • Review post-market surveillance activities, clinical evaluation reports, and design documents to ensure collection of data needed for technical documentation establishment or revision.
          Other Responsibilities
          • Focus on achieving our Company mission
          • Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality, compliance, and safety.
          • Inspire the trust of others; treat people with respect and dignity, and embrace the value of diversity.
          • Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
          • Contribute to building and maintaining a positive team environment.
          • Assure all policies and guidelines are implemented and followed.
          • Communication - Effectively providing information to supervisors and coworkers by telephone, in written form, email, or in-person.
          • Developing specific goals and plans to prioritize, organize, and accomplish your work.
          • Analyzing information and evaluating results to choose the best solution and solve problems.
          • Developing constructive and cooperative working relationships with others, and maintaining them over time.
          • Performing day-to-day administrative tasks such as maintain technical files and processing paperwork.
          • Getting members of our organization to work together to accomplish tasks.
          • Training others on the importance and requirements related to technical files and documentation.
            Quality Policy:At SunMed, Quality is our promise. It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.ExcellenceWe are dedicated to providing the quality of excellence through teamwork, leadership, open communication and continuous improvement to achieve the company's objectives and meet our customer's expectations.Continuously improve the effectiveness of our Quality Management System that delivers compliant and sustainable products, processes and systems.CustomersWe will adapt to customers changing needs at all times in an environment of continuous improvement of high quality products and services.ProductsWe distribute products that are safe, reliable and in compliance with applicable US and International regulatory requirements, standards and regulations.
            #sunmedcareers #regulatory #technicalwriter #GRJobs #medicaldevice

Keywords: SunMed, Grand Rapids , File Manager, Executive , Grand Rapids, Michigan

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