Engineering Manager - Hyderabad, India - AMS

Description

We are hiring for a MedTech organization which is a prominent player in the medical device industry, recognized for its commitment to advancing healthcare through cutting-edge technologies and therapies. With operational and executive headquarters based in U.S.A. and having global presence in more than 150 countries, making a positive impact on the lives of individuals worldwide.

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.