Regulatory Affairs Specialist

Remote

 

The function of the RA Specialist role is to support regulatory affairs activities for Tecan facilities globally ensuring compliance under all required company policies, procedures, and local laws for the commercialization of products inclusive of IVDs and medical devices globally. This team member will be part of the Global Regulatory Team with a focus on product-related regulatory activities. This includes:

 

Primary activities:

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 events 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 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 on Global regulatory affairs projects and initiatives as assigned.

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

 

Essential Functions

Defines regulations applicable to product lines and facility activities for areas of responsibility Documents regulatory strategies  Review and approve product labeling ensuring compliance with territories commercialized in. Performs and documents reviews for Adverse events and Field Corrective Actions. Interfaces mainly with the FDA/Health Canada, Latin America for product recall, and adverse event reporting. Performs contract/tender review where applicable for regulatory provisions. 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.

 

Skills

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 an engaging presentation style. Must have good technical writing skills Able to work effectively remotely with multiple facilities 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.

 

Experience

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 3 years of experience with GMP and regulated products. Knowledge and application of Food and Drug Administration and Health Canada requirements required. Knowledge of Latin American Medical Device regulations, MDD/MDR and IVDD/IVDR, and ROW regulations helpful. Practical knowledge of Microsoft Word, PowerPoint, Teams, SharePoint and Excel Knowledge of the Code of Federal Regulations (e.g. 21 CFR 820) and ISO 13485/9001 is required Regulatory or Compliance or Quality experience in FDA (21CFR Part 803/807/806) and Health Canada incident and recall reporting is a big advantage