Class II/III Regulatory Affairs

Job Opening for Class II/III Regulatory Affairs Consultant- Remote

We are currently working on below mentioned i., e. Job Opening for Class II/III Regulatory Affairs Consultant- Remote. Please let me know if you are interested in applying for the same.

Class II/III Regulatory Affairs Consultant-REMOTE, 40 HOURS/WEEK

Project: Our client is a large medical device manufacturer of class II/III endo surgery products. They are in need of a Regulatory Affairs consultant to come in and help complete 30-day notices, change orders, 180-day notices and life cycle management to be submitted to the FDA. Our client is looking for a very hands-on consultant who can be urgent with submission work.

Principle Duties and Responsibilities:

The consultant will be from the medical device industry and will have done experience with class II and III US submissions. The consultant will need to work with internal resources to locate information and needs to understand what information is required in the 30- and 180-day notices to get it approved. Very hands on role so must be comfortable writing dossiers. These activities are around post market PMA post approvals. Experience tech files, and design dossiers is a huge plus but experience with Class III and PMA submissions is a must. The ideal candidate will have endo experience and will have worked on both 510(k)s and PMAs. If you have experience with Health Canada and EU MDR that is a plus.

Required:

Medical Device
Reg Affairs
PMA writing/submissions
510(K) experiences
International/ Domestic Regulations
Hands on experience
Class II and III experience
30-day Notice
EU MDR

Job Summary :  This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).
Manage and coordinate the performance of all laboratory procedures, test analyses and quality assurance in compliance with USP.
Coordinate all batch record responsibilities including, issuing, reviewing and final review.

Summary of Essential Job Functions
Ensure compliance with company policies and business practices including FDA (Food & Drug Administration) regulations, GMP (Drug and Device Good Manufacturing Practices) and ISO (International Organization for Standardization) Medical Device Quality Systems requirements.
Perform microbial identification and Bioburden, quality control and growth promotion of microbiological media.
Authors Quality Systems documents and reviews Batch Records, as well as prepare certifications for customers.
Train and support multiple quality functions as needed: Environmental Monitoring, Calibration, Quality Auditing, Incoming Inspection, Complaints, Finished Product Release, etc.
Participates in and supports the CAPA process, including initiation, investigation and closure of CAPAs as required.
Participates and supports internal audits as well as external audits (FDA, ISO).
Perform supplier audits.
Lead investigator in major lab OOS reports (sterile positive).
Conduct manufacturing and laboratory investigations for out of specification results, non-conformances, and CAPA's.
Assist with training of individuals on the technical, record keeping, and current GMP aspect of their positions
Assists in quality systems compliance activities as directed by Director of Quality.
Authorized to make decisions based on existing Divisional / Site procedures and applicable regulations.
Determine the suitability of product for release based upon aseptic and microbiology data.
Evaluate new equipment and make purchasing recommendations.
Recommend product selections relative to raw materials and cleaning solutions.
Recurring physical demands include sitting, standing, walking, crouching, using tools, frequently lifting up-to 30 pounds.
Other duties as assigned.

Minimum Requirements

Working experience in microbiology laboratory environment (e.g. BET, Sterility, Water Quality, and Environmental Monitoring Testing) required with at least 2+ years handling pharmaceuticals / medical devices plus working experience in Quality System.
Knowledge of pharmaceutical / medical device manufacturing cleanliness, aseptic processing, and associated standards and guidance.
Understanding of microbiology and aseptic processing specific language, and knowledge of microbiology principles including Environmental Monitoring and Controls.
Knowledge in cleanroom design, cleanroom testing requirements and data trending / monitoring.
Knowledge in completing root cause analysis for microbiological excursions, implementing / recommending corrective actions and monitoring for effectiveness.
Must have knowledge of medical device / pharmaceutical regulations including cGMP / QSR and ISO / EN requirements for manufacturing quality systems.
Knowledge of Blow-Fill-Seal experience is desired but not required.
Calibration experience and internal auditing experience preferred.

Skill Requirements
Excellent written and verbal communication skills to effectively communicate with all levels of the organization.
Proficient computer skills (Work, Excel).
Ability and willingness to learn and retain key process information, analyze and interpret complex documents.
Ability to build effective relationships, integrate need of all stakeholders, both internal and externally with a customer focus.
Ability to work independently, prioritize work assignments to support production schedules and escalate issues as needed.
Detail-oriented.
Flexibility to take over / assist with the activities required to include overtime and / or occasional travel (expect less than 5%).
Working knowledge of and ability to use autoclave and sterile test equipment.
Demonstrated dexterity and other attributes required to accurately perform testing – aseptic sterility, environmental testing, bioburden, and more as required.
Ability to handle stress effectively.

Job Opening for Class II/III Regulatory Affairs Consultant- Remote

We are currently working on below mentioned i., e. Job Opening for Class II/III Regulatory Affairs Consultant- Remote. Please let me know if you are interested in applying for the same.

Class II/III Regulatory Affairs Consultant-REMOTE, 40 HOURS/WEEK

Project: Our client is a large medical device manufacturer of class II/III endo surgery products. They are in need of a Regulatory Affairs consultant to come in and help complete 30-day notices, change orders, 180-day notices and life cycle management to be submitted to the FDA. Our client is looking for a very hands-on consultant who can be urgent with submission work.

Principle Duties and Responsibilities:

The consultant will be from the medical device industry and will have done experience with class II and III US submissions. The consultant will need to work with internal resources to locate information and needs to understand what information is required in the 30- and 180-day notices to get it approved. Very hands on role so must be comfortable writing dossiers. These activities are around post market PMA post approvals. Experience tech files, and design dossiers is a huge plus but experience with Class III and PMA submissions is a must. The ideal candidate will have endo experience and will have worked on both 510(k)s and PMAs. If you have experience with Health Canada and EU MDR that is a plus.

Required:

Medical Device
Reg Affairs
PMA writing/submissions
510(K) experiences
International/ Domestic Regulations
Hands on experience
Class II and III experience
30-day Notice
EU MDR

Job Summary :  This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).
Manage and coordinate the performance of all laboratory procedures, test analyses and quality assurance in compliance with USP.
Coordinate all batch record responsibilities including, issuing, reviewing and final review.

Summary of Essential Job Functions
Ensure compliance with company policies and business practices including FDA (Food & Drug Administration) regulations, GMP (Drug and Device Good Manufacturing Practices) and ISO (International Organization for Standardization) Medical Device Quality Systems requirements.
Perform microbial identification and Bioburden, quality control and growth promotion of microbiological media.
Authors Quality Systems documents and reviews Batch Records, as well as prepare certifications for customers.
Train and support multiple quality functions as needed: Environmental Monitoring, Calibration, Quality Auditing, Incoming Inspection, Complaints, Finished Product Release, etc.
Participates in and supports the CAPA process, including initiation, investigation and closure of CAPAs as required.
Participates and supports internal audits as well as external audits (FDA, ISO).
Perform supplier audits.
Lead investigator in major lab OOS reports (sterile positive).
Conduct manufacturing and laboratory investigations for out of specification results, non-conformances, and CAPA's.
Assist with training of individuals on the technical, record keeping, and current GMP aspect of their positions
Assists in quality systems compliance activities as directed by Director of Quality.
Authorized to make decisions based on existing Divisional / Site procedures and applicable regulations.
Determine the suitability of product for release based upon aseptic and microbiology data.
Evaluate new equipment and make purchasing recommendations.
Recommend product selections relative to raw materials and cleaning solutions.
Recurring physical demands include sitting, standing, walking, crouching, using tools, frequently lifting up-to 30 pounds.
Other duties as assigned.

Minimum Requirements

Working experience in microbiology laboratory environment (e.g. BET, Sterility, Water Quality, and Environmental Monitoring Testing) required with at least 2+ years handling pharmaceuticals / medical devices plus working experience in Quality System.
Knowledge of pharmaceutical / medical device manufacturing cleanliness, aseptic processing, and associated standards and guidance.
Understanding of microbiology and aseptic processing specific language, and knowledge of microbiology principles including Environmental Monitoring and Controls.
Knowledge in cleanroom design, cleanroom testing requirements and data trending / monitoring.
Knowledge in completing root cause analysis for microbiological excursions, implementing / recommending corrective actions and monitoring for effectiveness.
Must have knowledge of medical device / pharmaceutical regulations including cGMP / QSR and ISO / EN requirements for manufacturing quality systems.
Knowledge of Blow-Fill-Seal experience is desired but not required.
Calibration experience and internal auditing experience preferred.

Skill Requirements
Excellent written and verbal communication skills to effectively communicate with all levels of the organization.
Proficient computer skills (Work, Excel).
Ability and willingness to learn and retain key process information, analyze and interpret complex documents.
Ability to build effective relationships, integrate need of all stakeholders, both internal and externally with a customer focus.
Ability to work independently, prioritize work assignments to support production schedules and escalate issues as needed.
Detail-oriented.
Flexibility to take over / assist with the activities required to include overtime and / or occasional travel (expect less than 5%).
Working knowledge of and ability to use autoclave and sterile test equipment.
Demonstrated dexterity and other attributes required to accurately perform testing – aseptic sterility, environmental testing, bioburden, and more as required.
Ability to handle stress effectively.