Product Manager

About the Company - Module Innovations

We are building Innovative diagnostic solutions for Infectious disease and Anti- Microbial Resistance (AMR). Module is  leveraging the power of Nanotechnology and Biotechnology to create powerful solutions for ultra rapid diagnosis of Urinary Tract Infection (UTI) and Anti-microbial Susceptibility of the uropathogen. Antibiotics are lifesaving drugs, but rapidly emerging antimicrobial resistance is threatening that reality. Module Innovations’s mission is to preserve the lifesaving efficacy of antibiotics by providing diagnostic results in hours, rather than days, and we are building a multidisciplinary team of talented individuals to help achieve this mission. J

oining the Module team will give you an opportunity to harness your talent and advance your career by working with diverse and high-performing teammates tackling the most important healthcare challenges. 

More at www.moduleinnovations.com

Qualifications

Education:

• M. Tech / MS /M.Sc. / PhD in Bioengineering / Biomedical engineering / Chemical Engineering / Materials Science /  Physical chemistry / Biotechnology / Biochemistry, Life Science or related fields

Experience:

• M.Tech/MS/M.Sc. with 5+ years in biomedical / life science applications or PhD with 1+ years of experience is an asset 
• Experience working in a national/international research institute or in a regulated industry, such as pharmaceuticals, in-vitro medical device development
• Certificate for an internal auditor for ISO 13485:2016 is an asset 
• Proven track record of successfully launching and managing in-vitro medical device following CDSCO regulations

Preferred Knowledge

• Knowledge of CDSCO MDR 2017 guidelines
• Knowledge of Project management software/tools like JIRA, Zoho
• Strong grasp and significant experience working with Microsoft Excel, PowerPoint, Word and other product management tools

Detailed Job Description

• Conduct market research and competitive analysis to identify opportunities and threats.
• Develop comprehensive project plans, including timelines, milestones and resource allocation
• Define project scope, objectives, and deliverables in collaboration with senior management and stakeholders.
• Identify and mitigate project risks and issues, ensuring timely resolution and escalation when necessary.
• Facilitate effective communication and collaboration among team members, stakeholders, and external partners
• Ensure products meet quality standards and regulatory requirements 
• Stay updated on industry trends and emerging technologies to drive innovation
• Work closely with teams to develop go-to-market strategies and launch plans 
• Track and report on product development metrics, including timelines, budgets, and performance outcomes.
• Provide regular updates to senior management on project status and key milestones
• Evaluation and documentation for Design and Development of in-vitro medical device and maintain its records in accordance with QMS.
• Conduct regular project reviews and audits to ensure compliance and identify areas for improvement
• Evaluate clinical validation of the product and ensure the quality is met.
• Engage with R&D team, clinicians, clinical microbiologists, lab technicians and maintain documentation for the same
• Facilitate project meetings, presentations, and reports for stakeholders at various levels
• Supervise the junior team, work closely with them, and make sure that the milestones are met within timelines.
• Support the organization by preparing and maintaining the documents for audits for the Quality Management System (QMS)
• Prepare reports and documents for regulatory compliance including CDSCO, 510(k) submissions, or CE Mark applications and support regulatory reviews
• Present project updates, findings, and recommendations to management and regulatory bodies.
• Follows and ensures aspects related to safety, ethics, confidentiality, and legal compliance
• Ensure full compliance with safety, health, and environmental (EHS) guidelines according to Module’s standards in all areas of responsibility.
• Promote safety according to the above guideline
• Actively participate in the planning and execution of the Module’s extracurricular activities such as workshops, AMR seminars, tech showcase

Our Company is an equal-opportunity employer and does not discriminate against any employee or applicant based on age, color, disability, gender, national origin, race, religion, sexual orientation or parental status.