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Do you want to make a significant difference in how the world is looking tomorrow and contribute to the innovation of state-of-the-art, cutting-edge technology products?

Then look no further and join our Quality team in Morrisville, NC as a

Regulatory Affairs Specialist

What you will do

 

Function of the RA Specialist role is to support regulatory affairs activities for assigned Tecan facilities globally ensuring compliance under all required company policies, procedures and local laws for commercialization of products inclusive of medical devices globally. This includes:

  • 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.
  • Interfacing with Product Managers on advertising content approval
  • 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.
  • Conducting Regulatory Intelligence monitoring for new or revised regulations in areas of assigned responsibilities.
  • Providing training to facilities under area of responsibility on various regulatory topics.
  • Contributing to improvement and advancement of regulatory affairs processes globally.  Participating on Global regulatory affairs projects and initiatives as assigned.
  • 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.

Responsibilities will include

 

  • Defines regulations applicable to product lines and facility activities for areas of responsibility
  • Documents regulatory strategies under guidance of supervisor
  • Review and approves product labelling ensuring compliance with territories commercialized in.
  • Review and approves advertising for products ensuring compliance with country specific regulations and product DHF
  • Performs and documents reviews for Adverse event and Field Corrective Actions.  Interfaces mainly with the FDA/Health Canada, Latin America for product recall, adverse event reporting.
  • Performs contract/tender review where applicable for regulatory provisions.
  • Creates or modifies regulatory procedures as assigned.
  • 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.

 

What you bring along

Experience

  • BS degree required
  • Prior experience with reagent based/consumable IVD or Medical Devices or life science product lines in Regulatory Affairs or Regulatory Compliance or Quality required.  Knowledge of instrument systems (laboratory equipment, IVD analyzers) helpful.
  • 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 and IVDD/IVDR, and ROW regulations helpful.
  • Practical knowledge of Microsoft Word, PowerPoint 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


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 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.


What you will get

  • Comprehensive Compensation and Benefits package
  • Progressive employment conditions
  • Exciting career opportunities
  • Wide range of training courses
  • International and diverse environment (30+ different nationalities)
  • Strong company culture with rich history
  • Global mindset with “Swissness” at heart

 

Look no further and apply now!

We are looking forward to receiving your application online. Please submit your resume (w/o picture and w/o cover letter, reference letters and diplomas are optional).

 

We will only consider applications that fully meet our requirements.

 

 

#RegulatoryAffairs #lifesciences #QARA

Every lab. Every day. Empowered.
Our vision is to empower every laboratory, every day, around the world with Tecan technology, products and support. We will help to shape the future of automated workflows in life sciences and clinical diagnostics through unrivaled expertise, products and customer support.

We care about our culture.
Our values – trust, highest standards and ambition – are the cornerstones of our business, and give us the framework for the Tecan culture. We foster a positive and empowering environment, which allows us to bring our passion and energy to work. This helps us to deliver on our customer promise – ‘Always there for you’.

Legal entity:  Tecan US Inc.
City:  Morrisville, NC
Country:  US