Engineering Manager
1 month ago
Engineering Manager - Medical Device Regulation
Job Responsibilities:
Oversee the company's drug or medical devices surveillance program, managing intake, protocol development, evaluation, processing, and follow-up on adverse reports.
Ensure accurate maintenance and reporting of Medical Device Reports (MDRs) and Adverse Drug Experience (ADE) data as mandated by regulatory agencies.
Review and analyze clinical databases to extract ADE data and integrate it into a unified database, ensuring accuracy and quality of safety summaries.
Act as a liaison internally and externally to develop programs and processes meeting regulatory reporting requirements.
Provide leadership to a team handling complaints, evaluating strategies for operational transformation and continuous improvement.
Evaluate incoming complaint information, maintain electronic records, and conduct follow-up activities to gather additional data.
Determine reportability of complaints to government agencies and categorize them appropriately to ensure trend accuracy.
Collaborate with various departments within the company and external entities such as customers, vendors, and healthcare professionals.
Minimum Qualifications:
Bachelor's degree in Engineering or Science (e.g., SW, EE, ME, Biomedical Engineering) preferred.
20+ years of quality assurance or regulatory experience in the medical or pharmaceutical industry.
Proficiency in Word, Excel, Access, PowerPoint, and database trending analysis.
Strong typing skills and ability to write business documents with minimal supervision.
Excellent verbal and written communication skills with a team-oriented approach.
Proactive leadership ability to lead technical initiatives.
Strong multitasking skills.
Understanding of complex medical device functionality and intended use.
Occasional travel may be required.
Differentiating Factors:
Autonomy: Manage subordinate supervisors and/or experienced professionals with latitude and independence in assignments.
Provide tactical and/or operational leadership and coaching.
Establish operational plans and implement policies and strategies impacting program schedules and customer satisfaction.
Propose modifications to functional operating policies and processes to drive continuous improvement.
Handle complex and undefined problems requiring detailed analysis and investigation.
Communicate effectively with internal and external stakeholders, influencing cooperation without direct command.
Manage a team of supervisors and/or experienced professionals, authorizing hiring, firing, promotion, and rewards within the area.
Knowledge of medical device development and quality control.
Familiarity with FDA, MEDDEV, and Canadian Regulations.
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