Global Regulatory Operations Specialist: SDS & Compliance

Twistbioscience; Portland (OR); In loco; USD 70.000 - 100.000; Tempo pieno

Descrizione del lavoro

Twist Bioscience is seeking a Regulatory Operations Specialist to ensure compliant management of regulatory documentation, with a focus on SDS, product labeling, and SOPs across global markets.

You will develop SDSs, obtain necessary hazard data, and coordinate with cross-functional teams for regulatory accuracy while maintaining EQMS records and documentation controls in a fast-paced biologics environment.

Competenze

• Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Biochemistry) or equivalent combination of education and work-related experience.
• Experience with medical device regulations ISO 13485 and EU IVDR; experience supporting regulatory documentation in an IVD or medical device environment.
• 2 years of experience Regulatory Operations within a biotechnology, life sciences, or chemical manufacturing company or another Regulated Industry.
• Expertise in developing technical documentation, including Safety Data Sheets (SDS), SOP, and work instructions.
• Familiarity with Quality Management Systems and electronic document control systems (eQMS).
• Experience with Google Suite and/or MS Office Products required.
• Experience with Master Control, Atlassian Confluence and/or JIRA preferred.
• Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience) required.
• Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands is required.

Mansioni

• Initiate, author, and maintain Safety Data Sheets (SDS) for all Twist products, ensuring compliance with global regulations.
• Collaborate with cross-functional teams to obtain necessary product composition data and hazard information for accurate SDS generation.
• Manage the review, approval, and distribution of SDS to internal and external stakeholders.
• Carries out duties in compliance with established business policies.
• Perform day to day administration activities on EQMS as per approved procedures.
• Work closely and collaborate with the Business Process Owner and EQMS users to develop and document configuration changes to meet business need.
• Perform other duties & projects as assigned.
• Ability to travel 5%.
• Follow regulatory and ISO 13485 requirements.

Conoscenze

Communication skills

Adaptability

Cross-functional collaboration

Attention to detail

Regulatory documentation experience

Formazione

Bachelor's degree in a scientific discipline

Strumenti

Master Control

Confluence

JIRA

eQMS

Google Suite

MS Office

Descrizione del lavoro

Twist Bioscience is seeking a Regulatory Operations Specialist to ensure compliant management of regulatory documentation, with a focus on SDS, product labeling, and SOPs across global markets.

You will develop SDSs, obtain necessary hazard data, and coordinate with cross-functional teams for regulatory accuracy while maintaining EQMS records and documentation controls in a fast-paced biologics environment.