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Title: Regulatory Affairs Associate

Hiring Organization: Connexion Systems & Engineering

• Duration: Perm           
• Pay rate: $ 80-85k
• Job Location: Danvers, MA
• Job# 14657

Regulatory Affairs Associate

Overview: Support the organization's Regulatory Affairs and Quality Assurance functions in multiple areas including documentation, compliance, audits, and regulatory submissions.

Responsibilities:

• Assists, coordinates, or prepares US and international regulatory submissions.
• Prepares or coordinates responses as requested by regulatory agencies or agents.
• Prepares or maintains MDD technical files and related documentation.
• Reviews clinical protocols to ensure appropriate collection of data to fulfill regulatory requirements.
• Ensures all quality operating procedures (QOP), work instructions (WI), or policies are in compliance with EN ISO 13485:2016.
• Reviews product promotional materials, labeling, records, specification sheets, or test methods for compliance with applicable regulations and policies.
• Maintains knowledge base of existing and emerging regulations, standards, or guidance documents.
• Participates in internal audits, external supplier audits, and MDSAP surveillance audits.
• Other duties as assigned

Qualifications:

• Bachelor's degree in life sciences or engineering.
• Minimum of 1-year experience in IVF, embryology, biotechnology, or pharmaceutical industry.
• Knowledge of electromechanical equipment and programmable systems preferred
• Strong verbal and written communication skills.
• Detail-orientated with demonstrated problem-solving skills and ability to multi-task.
• Proficient in Microsoft Office suite (Word, Excel, Outlook).

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