Clinical Regulatory Affairs Specialist   

The Clinical Regulatory Affairs Specialist is responsible for maintaining documentation, regulatory compliance, file maintenance, and understand current and upcoming regulations and policies for various clinical evaluations. Completes The individual is responsible for ensuring compliance to 21 CFR 820, 21 CFR Part 58, 21 CFR Part 56, ISO 13485, EU IVDR, CLIA/CAP, and other applicable international / local regulatory requirements.

Key Responsibilities:

  • Maintain a knowledgebase of new and existing regulations that impact the Twist products and the relevant clinical trial requirements.
  • Use knowledge of regulations to develop or standardize business operations and establish clearly documented procedures to support Regulatory requirements and submissions.
  • Providing input to global product support teams regarding product safety and effectiveness after commercialization.
  • Maintain data and files for future reference, especially in the event of an audit by a regulatory agency.
  • Preparing for and facilitating third party audits as necessary.
  • Acting liaison between Medical Affairs, Regulatory Affairs, QA and state, federal, and international agencies to submit required forms and paperwork as needed.
  • Ability to recommend courses of remediation based on knowledge of regulations to assist the organization to achieve the necessary levels of compliance.
  • Comfortable discussing regulatory policies with Medical Affairs, Executive Team, Clinical Diagnosis Laboratories, core teams, and customers when necessary.
  • Responsible for inputting large quantities of data accurately, while also able to determine potential problems or discrepancies in data and resolve or bring to the attention of Regulatory Affairs and Quality Assurance.
  • Assist as needed with Research Information Seminars to recruit participants by discussing eligibility and requirements for enrolling or upcoming clinical trials.
  • Work and communicate regularly with Clinical Research Coordinators to access study needs.
  • Research and maintain company records of regulatory issues and guidance.
  • Perform quality work within deadlines with or without direct supervision.
  • Interact professionally and ethically with coworkers, laboratory geneticists, business owners, and customers.
  • Work effectively as a team contributor or given assignments as needed.
  • Work independently while understanding the necessity for communicating and coordinating work efforts with Regulatory Affairs and Quality Assurance.
  • Effectively influences and trains employees (as required).
  • Maintains strong communication network with peers.
  • Demonstrated effective knowledge and use of various computer systems
  • Additional responsibilities as assigned 

Qualifications 

  • Bachelors or MS related areas (ex. Clinical pathology, biochemistry, clinical chemistry, molecular biology, biology, biomedicine).
  • Minimum 4 years related experience in relevant medical diagnostic/device industry, with knowledge of Clinical Trial submission requirements.
  • High ethical standards.
  • Familiarity with regulatory requirements for IVD Products, ISO 13485, 21CFR820, EU IVDR, CLIA, applicable experience in medical device, or biotech manufacturing and a thorough knowledge and understanding of cGMP.
  • Highly organized, with ability to prioritize own tasks and ability to work effectively virtually in conducting internal and external business.
  • Strong interpersonal skills.
  • Excellent oral and written communication skills, including the ability to articulate clear messages from complex data/information.
  • Ability to work across functions throughout a global organization at all levels.
  • Willing to travel up to 20%, as needed.

COVID-19 Vaccine Requirement: As of October 24,2021, all Twist Bioscience employees must be vaccinated against the COVID-19 virus.  The company will follow an accommodation process for medical and religion exemptions.

About Twist Bioscience 

At Twist Bioscience, we work in service of customers who are changing the world for the better. In fields such as medicine, agriculture, industrial chemicals and data storage, by using our synthetic DNA tools, our customers are developing ways to better lives and improve the sustainability of the planet.

Twist Bioscience Corporation is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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