COMPANY

OriGen Biomedical, Inc., is a global leader in cryopreservation and cell culture. We collaborate with top researchers, clinicians, and business partners to enhance solutions, improve patient outcomes, and achieve customer satisfaction by providing safe and effective products that positively impact the quality of life.

POSITION SUMMARY

OriGen Biomedical is a global leader in cryopreservation and cell culture. We collaborate with top researchers, clinicians, and business partners to enhance solutions, improve patient outcomes, and achieve customer satisfaction by providing safe and effective products that positively impact the quality of life. Reporting directly to the Director of Quality and Regulatory Affairs, the Regulatory Affairs Specialist will interface daily with Manufacturing, Operations, Research and Development, Customer Service, and Marketing in our corporate offices in Austin, TX.

REQUIRED SKILLSETS

• Must be detail-oriented
• Must be proficient on a computer, possessing basic navigation and program knowledge
• Must be able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
• Must be able to read, write, speak and fully understand English

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, & ABILITIES)

• A Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.
• 5+ years experience in a regulated industry (e.g., medical products), focusing on regulatory affairs and interactions with global regulatory authorities.
• Experience interfacing with the FDA or international regulatory agencies.
• Experience in the medical device industry preparing regulatory submissions.

PREFERRED QUALIFICATIONS

• Completion of RAPS Regulatory Affairs Certification (RAC) program or Regulatory Compliance Certification (RCC) desired.
• Lean Six Sigma Certification is a plus.
• Direct experience in or direct contributions to regulatory labeling.
• Experience using medical device labeling software.

NOTE

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship

The essential duties and responsibilities of this position include, but are not limited to the following:

• Evaluate regulatory risks and perform regulatory assessments of policies, processes, and procedures to new and existing or modified medical devices.
• Provide regulatory input to product lifecycle planning and anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Provide strategic input and technical guidance on regulatory requirements to development teams, including determining submission and approval requirements.
• Ability to serve as subject matter expert for regulatory labeling and streamlining labeling operations and all associated label templates in the quality management system.
• Compile, prepare, review and submit regulatory submissions and renewals to authorities and assess the acceptability of quality, preclinical and clinical documentation for submission filing.
• Participate in project teams for purposes of identifying regulatory requirements.
• Plan for and coordinate meetings with regulatory authorities, responding to requests while developing and maintaining effective relationships.
• Collaborate with regulatory representatives of international distributors and/or affiliates to ensure continued compliance with international regulations.
• Reviews device labeling and marketing materials for compliance with global regulations.
• Maintain regulatory files to ensure the company’s compliance with regulatory requirements.
• Develop, review, and approve quality system documentation such as regulatory strategic plans, procedures, verification, and validation protocols and reports, and investigations (e.g., complaints, CAPAs, nonconformances, or deviations).
• Collaborate with Engineering, Quality Assurance, Operations, and Marketing to fulfill design control activities and other product development deliverables, including establishing regulatory project timelines.
• Ensure procedures and processes are maintained and updated to be consistent with regulatory requirements; Leads effective meetings, conducts presentations, keeps and maintains regulatory and quality records, and meeting minutes.
• Work closely with Quality to support audits/inspections.
• Utilize technical regulatory skills to propose strategies on complex issues and implement strategies that will ensure company compliance with regulatory requirements and timely marketing approvals or product registrations.