Project Manager
Jeffersonville, IN · On-site
Familiarity with and managing efforts for compliance with ISO standards, country-specific (FDA, MDR, Health Canada, PMDA, etc.), GMP regulations, and customer requirements. * Input and review for ...
Project Manager
Jeffersonville, IN · On-site
Familiarity with and managing efforts for compliance with ISO standards, country-specific (FDA, MDR, Health Canada, PMDA, etc.), GMP regulations, and customer requirements. * Input and review for ...
Strong knowledge of aseptic processing and validation in a globally regulated industry (FDA, EMEA, PIC/S, Japan PMDA, etc.) * Computer proficiency in Microsoft Word, Excel, and Outlook and the ...
Strong knowledge of aseptic processing and validation in a globally regulated industry (FDA, EMEA, PIC/S, Japan PMDA, etc.) * Computer proficiency in Microsoft Word, Excel, and Outlook and the ...
Strong knowledge of aseptic processing and validation in a globally regulated industry (FDA, EMEA, PIC/S, Japan PMDA, etc.) * Computer proficiency in Microsoft Word, Excel, and Outlook and the ...
Strong knowledge of aseptic processing and validation in a globally regulated industry (FDA, EMEA, PIC/S, Japan PMDA, etc.) * Computer proficiency in Microsoft Word, Excel, and Outlook and the ...
Pmda information
What are the key skills and qualifications needed to thrive as a PMDA (Pharmaceuticals and Medical Devices Agency) reviewer, and why are they important?
To thrive as a PMDA reviewer, you need an advanced degree in pharmaceutical sciences, medicine, or related fields, along with a thorough understanding of drug development and regulatory requirements. Familiarity with regulatory submission systems, guideline databases, and scientific data analysis tools is essential. Strong analytical thinking, attention to detail, and effective communication are critical soft skills for this role. These competencies ensure rigorous evaluation of medical products, safeguard public health, and facilitate clear interactions with stakeholders.
What are PMDA and what do they do?
PMDA stands for Pharmaceuticals and Medical Devices Agency, which is a Japanese government agency responsible for reviewing, approving, and monitoring pharmaceuticals, medical devices, and regenerative medicines. They ensure the safety, efficacy, and quality of these products before and after they enter the Japanese market. PMDA also provides consultation services during the development process and post-marketing surveillance to protect public health.
What is the difference between Pmda vs Pharmacist?
| Aspect | Pmda | Pharmacist |
|---|---|---|
| Required Credentials | Typically requires a specialized certification or training in medical device regulation | Requires a pharmacy degree and licensure |
| Work Environment | Regulatory agencies, medical device companies, healthcare compliance | Community pharmacies, hospitals, healthcare settings |
| Industry Usage | Regulatory and compliance sectors within healthcare | Pharmaceuticals, healthcare, patient care |
While Pmda professionals focus on medical device regulation and compliance, pharmacists are licensed healthcare providers specializing in medication dispensing and patient care. Both roles are vital in healthcare but serve different functions and require distinct credentials.
What are some common challenges faced by a PMDA (Project Management Data Analyst), and how can they be addressed?
One common challenge for a PMDA is balancing the need for timely project updates with ensuring data accuracy and consistency across multiple sources. Since PMDAs often work with cross-functional teams, aligning everyone on standardized data reporting processes can be demanding. Building strong communication channels and implementing robust data validation tools can help overcome these challenges. Additionally, proactively seeking feedback from stakeholders and regularly updating documentation can streamline workflows and support project success.
What are popular job titles related to Pmda jobs in Indiana? For Pmda jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Pmda jobs in Indiana look for? The top searched job categories for Pmda jobs in Indiana are:
Full-time
Posted 23 days ago
Job description
Working at Freudenberg: We will wow your world!
Responsibilities:Lead development of accuratemanufacturing cost models, make-vs-buy decisions, work-center costs, and support quote generation and pricing strategy for new business or large sustaining initiatives.
Establish, track, and report key performance metrics for development, project progression, and launch; champion continuous-improvement and Lean/Six Sigma activities to boost quality, delivery, and cost.
Gather and translate user, customer, clinician, and/or market needs and inputs into clear product and business requirements; present data-driven recommendations to stakeholders.
Maintain project documentation in line with internal procedures and notified-body expectations, supporting audits and ensuring robust change-control and traceability. Prepare reports and project summaries to communicate the status of projects on a regular basis.
Provide technical and project-management leadership, set priorities, allocate tasks, mentor team members, and foster a culture of efficiency, innovation, and regulatory excellence across the organization.
Manages a few discrete projects with teams, operating within a defined PDP process delivering to achieve defined scope, schedule, and budget performance goals.
Familiarity with and managing efforts for compliance with ISO standards, country-specific (FDA, MDR, Health Canada, PMDA, etc.), GMP regulations, and customer requirements.
Input and review for design history files, device master records, risk analyses, and validation protocols/reports (IQ/OQ/PQ) to ensure designs, processes, equipment, and products meet client, regulatory, and business needs.
Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field.
3+ years' experience in Medical Device or related industry
2+ years' experience in leading teams in a manufacturing or engineering environment, with demonstrated experience of managing work within a project plan framework, including managing a schedule, budget, scope, progress, and reporting.
Understanding of scientific principles and manufacturing processes used in medical device production, such as running equipment, injection molding, extrusion, catheter manufacturing, and assembly, including the materials used.
Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills.
Understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971, and 45001. Knowledge of GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements (i.e., 21 CFR 820 in the United States, and EU MDR).
Demonstrated experience using Lean/Six Sigma tools as necessary for new and continuous improvement projects.
Demonstrated experience providing leadership and managing multiple projects of low to medium complexity.
The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.
Freudenberg Medical LLC