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  • 3 days ago

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About American Surgical Company

At American Surgical Company, we are pioneers in crafting precision surgical devices that enhance patient care and drive innovation in the medical field. We are headquartered in Salem, MA, and are dedicated to continuous improvement and excellence in our products and practices...

Location: Salem, MA (Potential for hybrid work arrangement)

The Role

We are seeking a dedicated Regulatory Affairs and Quality Assurance Associate to join our team. This role is critical in ensuring that our operations and products meet all regulatory standards and continue to set the benchmark for quality in the medical device industry.

Key Responsibilities
• Identify, evaluate, and ensure compliance with all applicable laws, regulations, and standards.
• Conduct thorough reviews and ensure compliance across all target markets.
• Manage and report on medical device adverse events and corrective actions.
• Support regulatory filings including IDE, 510(k), PMA, and CE Mark applications.
• Lead and represent the company in internal and external audits.
• Maintain and obtain necessary ISO and CE certifications.
• Develop and implement regulatory strategies for new technologies and product modifications.

What We Offer
• Comprehensive benefits package.
• A dynamic role at the heart of the medical device industry.
• A supportive and collaborative work environment.
• Opportunities for professional growth and career advancement.
• A commitment to work-life balance, offering hybrid work arrangements as feasible.

Who You Are
• You hold a bachelor’s degree in a clinical, engineering, or scientific discipline.
• You bring 3-5 years of relevant experience in a regulated medical device manufacturing environment.
• You are experienced with EU MDR, ISO 13485, FDA 510(k), and PMA.
• You possess strong analytical skills and are capable of interpreting complex regulatory documents.
• Excellent communication skills and the ability to work well under limited supervision are among your strengths.

Interested?

We'd love to hear from you! Join us in shaping the future of medical care by applying today.

American Surgical Company is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees
Salem MA USA

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