OriGen Biomedical Open Jobs

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

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.
• 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.

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

COMPETENCIES

• Manage and coordinate multiple large projects while guiding internal stakeholders on regulatory requirements.
• Effectively communicator both internally and externally.
• Knowledge of pertinent regulations in major jurisdictions (MDSAP and EU).
• Proven skills in preparing regulatory submissions in MDSAP regions and the EU. Experience with international regulatory submissions is a plus.
• Knowledge of FDA regulations and guidelines, including 21 CFR 820.
• Knowledge of ISO 13485, MDSAP, and EU MDR requirements.
• Self-starter managing day to day tasks and working in collaboration to accomplish deadlines and objectives.
• Interpersonal skills necessary for working effectively in a team environment.
• Works cross functionally to complete projects and testing.
• Exercises judgment within broadly defined practices and policies.
• Exceptional skills in using computer software and hardware applications, including Microsoft Word and Excel.
• Outstanding communication skills, both written and oral, in communicating across the organization and outside of the organization

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.

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 climate-controlled warehouse and/or professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. 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. The 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. 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 and may be required to operate automated warehouse equipment; e.g. electric pallet jack, or forklift. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus.

Travel

5%

Salary:

Morning Shift: Work hours: five days, 8-hour shifts (Monday-Friday 5:30am – 2:00pm).

Evening Shift: Work hours: four days, 10-hour shifts (Monday-Thursday  2:15pm – 12:45am). 

The Clean Room Tech (CRT) is responsible for the assembly, testing, and packaging of medical devices and components. Required to understand and comply with drawings, written procedures, batch records, and must apply these standards to their work.

Essential Duties and Responsibilities

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

• Ability to meet production schedules and deadlines according to quality standards
• Ability to work in a flexible and changing environment
• Ability to follow detailed written and verbal instructions
• Ability to learn multiple tasks and train in other areas as needed
• Ability to work with a variety of tools and equipment
• Ability to maintain all logs, paperwork, and forms accurately
• Required to understand, access, and make entries to documents on the company Electronic Document System
• Ability to accurately perform job duties with minimum supervision
• Ability to adhere to cleanroom dress code and policies
• Ability to work in a multi-cultural team environment and be a team player
• Ability to work in a cleanroom environment for extended periods of time
• Punctual and Reliable!!

Required Skill Sets

• Must be detailed oriented and be able to focus on a repetitive task for long periods of time
• 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

Competencies

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

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Basic computer navigation and program knowledge
• Strong organization and time management skills with the demonstrated ability to meet deadlines
• Pays very close attention to detail
• Ability to work independently and within a team environment  

Preferred Qualifications

• Prior Clean Room experience preferred

Compensation

Based on experience and ability

How to Apply

Interested candidates should send their resume, title(s) of job for which they wish to be considered, and salary requirements to origenjobs@origen.com. Unfortunately, due to the volume of candidates, it is not possible to follow up with all applicants, but we invite you to visit OriGen’s Career Page often, as we are updating with new opportunities frequently.  We look forward to hearing from you.

If you are interested in working at OriGen, but do not see a current opening that fits your skillset, please use the form below and you’ll be notified if a similar role becomes available.

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