Regulatory Operations Specialist - Temporary

Twistbioscience; Portland (OR); Sur place; USD 70 000 - 100 000; Plein temps

Résumé du poste

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.

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

Communication skills

Adaptability

Cross-functional collaboration

Attention to detail

Regulatory documentation experience

Formation

Bachelor's degree in a scientific discipline

Outils

Master Control

Confluence

JIRA

eQMS

Google Suite

MS Office

Description du poste

The Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on Safety Data Sheets (SDS), product labeling, and SOP's. This role is crucial in supporting global product compliance, ensuring that all documentation accurately reflects regulatory requirements and product specifications.

What You'll Be Doing

• 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.

What You'll Bring to the Team

• Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Biochemistry) or equivalent combination of education and work-related experience.
• Working knowledge of medical device regulations, including ISO 13485 and EU IVDR (In Vitro Diagnostic Regulation); experience supporting regulatory documentation in an IVD or medical device environment strongly preferred.
• 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.