Regulatory Affairs Coordinator

Remote Notary Jobs | Regulatory Affairs Coordinator Jobs

Job Responsibilities: Regulatory Affairs Coordinator

Salary: 65000 per YEAR

Company: Ortho Clinical Diagnostics

Location: Remote US

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing clinical chemistry and transfusion medicine. We are more than 6000 strong and do business in over 130 countries providing answers with fast accurate and consistent testing where and when they are needed most – from home to the hospital lab to the clinic.
Our culture puts our team members first and prioritizes actions that support happiness inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

The Regulatory Affairs Coordinator provides administrative support to the regulatory affairs team and leadership group. The coordinator facilitates the processing of regulatory documents and serves as the lead for requesting legalized documents necessary for medical device registration activities. Manages the internal processes for requesting purchase orders FDA site establishment registrations site licenses and annual reports. Maintains the RA calendars and prepares the department metrics.

The Responsibilities

  • Manage applications to the FDA for Certificates to Foreign Government (CFG) and Export Certificates. Review approve and submit FDA invoices FDA submission check requests and FDA forms.
  • Manage requests for regulatory document apostilles and legalization services.
  • Manage Regulatory calendar for the RA team and leadership. Provide awareness of team meetings holidays leave vacations and team activities.
  • Interact with the department team member to generate monthly metrics and reports to ensure consistency and accurate reporting.
  • Interact with global regulatory leaders and peers to share and manage department metrics and KPIs.
  • Interact with regulatory affairs team members to formulate/review standard operating procedures work instructions and other regulatory processes.
  • Provide administrative support to the regulatory submissions processes as needed such as formatting and/or publishing.
  • Monitor government industry and standards publishing agencies’ websites news feeds and distribution lists to track new and changing regulatory requirements.
  • Manage the FDA registration databases for device listings updates initial entries and changes.
  • Assist with onboarding of new RA associates.
  • Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
  • Provide notary services for the regulatory affairs group.

The Individual

  • Bachelor’s degree (BS/BA) in a scientific discipline is required; BS/BA in biological science is preferred.
  • Must be detail oriented with well-developed organizational and analytical skills.
  • Must have the ability to succeed in a fast-paced environment with proven ability to be flexible and adaptable within a changing dynamic environment.
  • Ability to interpret subjective and complex aspects of specific regulations and a thorough understanding of multiple sets of associated regulations.
  • Able to confidently deal with ambiguous issues and provide input toward suitable actions.
  • Strong oral and written communication and presentation skills.
  • Effective communicator of technical & non-technical information.
  • Ability to work in a self-directed manner to see issues through to completion.
  • IVD product experience is highly preferred.
  • Highly proficient in Microsoft Word Excel PowerPoint and Adobe Acrobat.
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