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Posted On: 09/16/2025 4:17:28 PM
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https://www.linkedin.com/jobs/view/4293645814/
82 applicants, no longer accepting applications.
BioElectronics Corp (BIEL) would likely need to hire a Medical Device Compliance Engineer to strengthen its regulatory and quality infrastructure—especially as it pushes deeper into clinical trials, VA partnerships, and potential commercialization of its RecoveryRx device.
Here’s why this role matters for BIEL:
Strategic Reasons for the Hire
1. Regulatory Compliance
Ensuring adherence to FDA regulations (21 CFR Part 820) and global standards like ISO 13485 and EU MDR is critical for expanding into new markets. BIEL’s RecoveryRx is a Class II medical device, so maintaining a robust Quality Management System (QMS) is essential.
2. Clinical Trial Support
The engineer would help compile and maintain Design History Files, Device Master Records, and risk management reports—all vital for FDA submissions and trial documentation.
3. VA and Government Contracts
If BIEL is pursuing contracts with the VA or DoD, it must meet strict compliance and post-market surveillance standards. This hire could help manage CAPA, complaints, and safety updates required for federal procurement. Having a compliance expert signals maturity and operational readiness. This hire could be instrumental in scaling operations to meet government procurement standards.
4. Global Expansion
The role includes liaising with regulatory bodies and distributors in other countries—suggesting BIEL may be eyeing international distribution. The job description mentions global regulatory support, suggesting BIEL may be eyeing EU MDR, Health Canada, or Asia-Pacific markets. A compliance engineer would help navigate country-specific device registrations, technical files, and clinical evaluation reports.
Signaling Maturity
This isn’t just a tactical hire—it’s a strategic signal. BIEL is showing investors, partners, and potential suitors that it’s evolving from a speculative OTC stock into a serious medtech contender. It’s a strategic move to professionalize operations, support growth, and position BIEL for bigger moves, whether that’s scaling sales, entering new markets, or becoming a viable merger target.
https://www.linkedin.com/jobs/view/4293645814/
82 applicants, no longer accepting applications.
BioElectronics Corp (BIEL) would likely need to hire a Medical Device Compliance Engineer to strengthen its regulatory and quality infrastructure—especially as it pushes deeper into clinical trials, VA partnerships, and potential commercialization of its RecoveryRx device.
Here’s why this role matters for BIEL:
Strategic Reasons for the Hire
1. Regulatory Compliance
Ensuring adherence to FDA regulations (21 CFR Part 820) and global standards like ISO 13485 and EU MDR is critical for expanding into new markets. BIEL’s RecoveryRx is a Class II medical device, so maintaining a robust Quality Management System (QMS) is essential.
2. Clinical Trial Support
The engineer would help compile and maintain Design History Files, Device Master Records, and risk management reports—all vital for FDA submissions and trial documentation.
3. VA and Government Contracts
If BIEL is pursuing contracts with the VA or DoD, it must meet strict compliance and post-market surveillance standards. This hire could help manage CAPA, complaints, and safety updates required for federal procurement. Having a compliance expert signals maturity and operational readiness. This hire could be instrumental in scaling operations to meet government procurement standards.
4. Global Expansion
The role includes liaising with regulatory bodies and distributors in other countries—suggesting BIEL may be eyeing international distribution. The job description mentions global regulatory support, suggesting BIEL may be eyeing EU MDR, Health Canada, or Asia-Pacific markets. A compliance engineer would help navigate country-specific device registrations, technical files, and clinical evaluation reports.
Signaling Maturity
This isn’t just a tactical hire—it’s a strategic signal. BIEL is showing investors, partners, and potential suitors that it’s evolving from a speculative OTC stock into a serious medtech contender. It’s a strategic move to professionalize operations, support growth, and position BIEL for bigger moves, whether that’s scaling sales, entering new markets, or becoming a viable merger target.
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