Job summary
Job post source
This job is directly from OriGen Biomedical
Job overview
The Regulatory Affairs Associate at OriGen Biomedical supports the Regulatory team in maintaining compliance with domestic and international medical device regulations, contributing to product safety and market access.
Responsibilities and impact
The role involves assisting with regulatory documentation, managing logs and systems, preparing dossiers for global submissions, monitoring regulatory changes, supporting labeling compliance, post-market surveillance, audits, and corrective actions.
Experience and skills
Requires a Bachelor's degree or equivalent in life sciences or related field, strong detail orientation, communication, organizational skills, and proficiency with Microsoft Suite; preferred experience includes 1+ year in regulated medical device environments and familiarity with relevant regulations and quality systems.
Career development
The position offers opportunities to learn regulatory strategies and grow professional skills within an established medical device company with international market presence.
Work environment and culture
The work environment is professional office and cleanroom settings, requiring teamwork, ethical conduct, adaptability, and effective communication.
Company information
OriGen Biomedical is a global leader in cryopreservation and cell culture, providing medical devices that improve patient outcomes and quality of life internationally.
Team overview
The Associate reports to the Regulatory Affairs Project Manager and collaborates with the Regulatory team and cross-functional project teams.
Job location and travel
The job operates primarily in a professional office environment with some cleanroom work, requiring physical activity and use of personal protective equipment.
Unique job features
The role is largely administrative, suitable for candidates new to regulatory affairs, with opportunities to engage in diverse regulatory tasks supporting global medical device compliance.
Company overview
OriGen Biomedical is a medical device manufacturer based in Austin, Texas, specializing in the design and production of high-quality cryopreservation, cell culture, and respiratory products for use in cell therapy, gene therapy, and critical care applications. The company generates revenue by supplying hospitals, research institutions, and biopharmaceutical companies worldwide with single-use sterile devices such as cryogenic storage bags, cell culture bags, and ECMO (extracorporeal membrane oxygenation) accessories. Founded in 1997, OriGen has built a reputation for innovation and quality, maintaining ISO certification and FDA registration for its products. The company’s focus on supporting advanced therapies and life-saving treatments has positioned it as a trusted partner in the rapidly growing regenerative medicine sector. Candidates should be aware of OriGen’s commitment to patient safety, regulatory compliance, and ongoing product development in response to evolving medical needs.
How to land this job
Position your resume to highlight your attention to detail, organizational skills, and proficiency with Microsoft Suite, as these are key for supporting regulatory documentation and data management at OriGen Biomedical.
Emphasize any experience or coursework related to regulatory frameworks, medical devices, or quality systems, even if limited, to demonstrate your eagerness to learn and adapt in a regulated environment.
Apply through multiple channels including OriGen Biomedical’s corporate career site and LinkedIn to maximize your application’s visibility and ensure it reaches the right hiring managers.
Connect with current Regulatory Affairs team members at OriGen Biomedical on LinkedIn; use ice breakers such as commenting on recent company news or asking about their experience working on international regulatory submissions to start a conversation.
Optimize your resume for ATS by incorporating keywords from the job description like 'regulatory compliance,' 'documentation management,' 'medical device regulations,' '21 CFR 820,' and 'ISO 13485,' ensuring your resume passes initial automated screenings.
Use Jennie Johnson’s Power Apply feature to automate tailored applications, identify the best job portals for submission, and find relevant LinkedIn contacts to network with, allowing you to focus more on preparing for interviews and skill development.
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