Regulatory Affairs Associate

Position Summary

OriGen Biomedical is a global leader in cryopreservation and cell culture. We enhance solutions, improve patient outcomes, and achieve customer satisfaction by providing safe and effective medical devices that positively impact quality of life. Reporting directly to the Regulatory Affairs Project Manager, the Regulatory Affairs Associate will support our Regulatory team in maintaining continuous compliance with domestic and international regulatory requirements.

The position is largely administrative and does not require previous regulatory affairs experience, but a desire to understand regulatory framework in the medical device industry is pertinent. Associates are offered the opportunity to learn regulatory strategies and gain valuable knowledge to grow their professional skillset with an established medical device company that has products in the U.S, Canada, E.U, and other international markets.

Essential Duties And Responsibilities

• The essential duties and responsibilities of this position include, but are not limited to the following:
• Assist in the development of content for Management Review and the Regulatory team, including templates, spreadsheets, and presentations
• Help maintain and organize regulatory documentation, ensuring documentation is accurate and up-to-date to support international registrations
• Manage regulatory logs and systems, such as documentation service requests (e.g., legalization, notarization, apostilles, embassy consularization, CFGs, etc.)
• Help maintain regulatory files, information, and databases to ensure data continuity by collecting information and entering it accurately into various applications
• Assist the Regulatory team in preparing detailed product dossiers and technical reports for global regulatory submissions
• Keep abreast of regulatory intelligence, assess the potential impact from new regulations, and support the development of appropriate change recommendations
• Act as regulatory representative on project teams, with oversight, and provide input
• Create and/or review product labeling and accompanying information for compliance with global regulations
• Support post market surveillance investigation and trending
• Prepare for and support internal and external auditing events
• Assist with field action investigations and vigilance reporting
• Support corrective/preventive action planning and execution
• Other duties and/or projects as assigned
  
  
  

Required Skillsets

• Must be detail-oriented
• Diligent in ensuring all steps of a process are followed and completed as required
• General problem-solving skills
• Must be proficient on a computer with exceptional skills in using and learning computer software applications, especially Microsoft Suite
• Self-starter managing day to day tasks and working in collaboration to accomplish deadlines and objectives
• Interpersonal skills are necessary to work effectively in a team environment, working cross-functionally to complete projects and testing
• Outstanding communication skills, both written and oral, in communicating across the organization and outside of the organization
• Strong organization and time management skills with demonstrated ability to meet deadlines
• Must be able to read, write, speak and fully understand English
  
  
  

COMPETENCIES

• Adaptability/Flexibility
• Ethical Conduct/Integrity
• Communication/Listening
• Detail-Oriented
• Interpersonal skills
• Personal Effectiveness
• Teamwork
  
  
  

Minimum Qualifications (knowledge, Skills, & Abilities)

• Bachelor’s Degree or equivalent work experience in life sciences, engineering, or a related field
  
  
  

Preferred Qualifications

• 1+ year working in a regulated environment with medical devices, either in quality/regulatory or another technical field
• Some experience with medical device laws, regulations, and industry standards, including 21 CFR 820, ISO 13485:2016 and MDSAP requirements
• Some experience with non-conformance and CAPA processes, including root cause analysis techniques
• Experience using an eQMS is preferable
  
  
  

SUPERVISORY RESPONSIBILITY

This position has no supervisory responsibilities. This position may be required to lead/report on projects and ensure participants meet deadlines.

WORK ENVIRONMENT

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. The noise level in the work environment is generally moderate however, periods of higher-level noise may occur.

This job may also operate in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom attire; e.g. coat, bouffant, face mask, and gloves.

• Must be able to stand or sit for extended periods of time. Must be able to wear personal protective equipment when required
  
  
  

PHYSICAL DEMANDS & WORK ENVIRONMENT

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is frequently required to stand, walk, climb, sit, stoop, bend and reach with hands and arms. The employee must frequently lift and/or move up to 50 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus.

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