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Company

Tecan · 6 hours ago

Regulatory Affairs Manager

North Carolina, United States

Full-time

Remote

Mid, Senior Level

5+ years exp

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Biotechnology

Hiring Manager

Ricardo Rocha

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Responsibilities

Working with new product development & commercialization teams to define regulatory standards, labeling, and commercialization requirements (i.e. registration, certification, listing, etc).

Assessing design changes for regulatory considerations as required.

Evaluating complaints for adverse event reportability and recall, documenting decisions, and filing as required

Partnering with QA to ensure products meet specified regulatory requirements for the territories products are commercialized in.

Providing training to facilities under the area of responsibility on various regulatory topics.

Interfacing with regulatory authorities as required in areas of responsibility.

Prepares and coordinates product registration packages and works collaboratively with internal project teams and external regulators or customers to ensure proper registration of Tecan’s products.

Interfacing with Product Managers and the Marketing team on advertising content approval

Conducting Regulatory Intelligence monitoring for new or revised regulations in areas of assigned responsibilities.

Contributing to the improvement and advancement of regulatory affairs processes globally.

Participating in Global regulatory affairs projects and initiatives as assigned

Support site inspections or audits from authorities, internal or customers as required

Defines regulations applicable to product lines for areas of responsibility

Documents product regulatory strategies

Review and approve product labeling ensuring compliance with territories commercialized in.

Performs and documents reviews for Adverse events and Field Corrective Actions.

Performs contract/tender review where applicable for regulatory provisions.

Leads and/or supports regulatory affairs projects as assigned.

Works on product registration as assigned.

Handles essential tasks as assigned, and responds to change productively.

Performs other duties as required.

May Travel up to 30 % as needed.

Qualification

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Regulatory AffairsIVD experienceMedical Devices experienceGMP knowledgeFDA requirements knowledgeHealth Canada requirements knowledgeRegulatory Compliance experienceTechnical writing skillsLatin American regulations knowledgeMicrosoft WordMicrosoft PowerPointMicrosoft ExcelMicrosoft TeamsSharePoint

Required

BS degree in scientific discipline or engineering, required

Prior experience with IVD or Medical Devices or life science product lines in Regulatory Affairs or Regulatory Compliance or Quality is required.

Minimum 5 years of experience with GMP and regulated products.

Knowledge and application of Food and Drug Administration and Health Canada requirements required.

Practical knowledge of Microsoft Word, PowerPoint, Excel, Teams, and Sharepoint

Knowledge of the Code of Federal Regulations

Must be able to communicate effectively at varying technical levels with an international audience and multiple levels of leadership.

Requires excellent written and verbal communication skills, including good facilitation skills, excellent presentation skills, and engaging presentation style.

Must have good technical writing skills

Able to work effectively remotely with multiple facilities and cultures in different time zones

Maintains and enhances technical abilities by continuing education, self-study, and company-sponsored training

Ability to recognize and communicate potential areas of compliance risks and work collaboratively to resolve them with integrity

Ability to communicate with and understand the needs of internal and external clients

Strong organizational skills

Ability to work well under pressure, to multitask

Strong interpersonal skills, high level of commitment and initiative, comfortable working independently

Proven team player

Must be approachable, informing, and respectful in dealing with internal employees and Tecan’s customers and partners

Ability to prioritize and manage time effectively.