ABOUT US:

Biolase MG is a leading innovator in medical laser technology, dedicated to improving patient outcomes through cutting-edge solutions. We’re seeking a Regulatory Affairs Specialist to support our compliance efforts and help bring our products to market efficiently and ethically.

POSITION OVERVIEW:

The Regulatory Affairs Specialist will play a key role in ensuring that our products comply with all applicable regulations and standards. You will collaborate with cross-functional teams to prepare and submit regulatory documentation, maintain product registrations, and support audits and inspections.

QUALIFICATIONS:

• Bachelor’s degree in Life Sciences, Engineering, or a related field
• 1–3 years of experience in regulatory affairs (medical device experience preferred)
• Knowledge of FDA regulations (21 CFR 820, 21 CFR 807), ISO 13485, and EU MDR
• Strong attention to detail and excellent written communication skills
• Ability to manage multiple projects and deadlines

• Prepare and submit regulatory filings (FDA, CE, etc.) for new and existing products
• Maintain product registrations and ensure ongoing compliance with domestic and international regulations
• Review product labeling, marketing materials, and packaging for regulatory compliance
• Support internal and external audits and inspections
• Monitor changes in regulatory requirements and assess their impact on business
• Collaborate with R&D, QA, and Manufacturing teams during product development and post-market activities