Join our RQMIS team

OVERALL RESPONSIBILITIES:

Provide overall support and management of client needs in the area of quality system design and management. This support shall assure that the client will achieve compliance with specified objective(s) in terms of regulations and standards conformance, as well as, operational effectiveness and efficiency. Provide support for the development, management and execution of client and/or public training courses in the area of quality system design/management/ compliance. Provide support for the development/implementation/management of tools for RQMIS employees in performing their duties.

POSITION DUTIES & RESPONSIBILITIES:

Assist and support client’s product development activities through interpretation and implementation of FDA’s Drug GMPs (21CFR211), Device GMPs (QSR 21CFR820), GTPs, ISO 13485 and ISO14971 requirements and other regulatory/standard requirements.

• Assist in developing and maintaining client’s quality system procedures, inspection instructions, and related documentation in support of product development, production and post market activities.
• Audit client’s quality system to assure compliance to the FDA’s GMPs, ISO 13485 and other regulatory/standards requirements.
• Develop and implement tools for RQMIS employees in conducting their activities.
• Develop/execute training programs used to educate clients or potential clients on how to implement regulatory and standard requirements.
• Assist in the development of manufacturing sections of regulatory submissions for domestic and international markets.
• Design and implement IQ/OQ/PQ for client equipment and processes.
• Ensure compliance with product postmarketing approval requirements
• Provide regulatory input for and appropriate follow-up to inspections and audits
• Identify product-associated problems and develop proposals for solutions
• Problem-solve with and advise clients on quality issues
• Communicate and negotiate with regulatory authorities and stakeholders

EDUCATION & PROFESSIONAL EXPERIENCE:

• Bachelor’s degree in engineering/technical field (biomedical, mechanical, chemical, electrical, biochemical engineer, chemist, microbiologist, etc.), or similar work experience.
• 4 to 6 years’ experience with medical device regulations/standards (including for domestic and international markets).
• Knowledge of domestic/international medical device regulations/standards/guidance’s.
• Strong attention to detail.
• Strong computer skills, including word processing, spreadsheet and data programs.
• Good oral and written communication skills.
• Good leadership skills.
• Ability to effectively manage multiple tasks while continuously assessing company and/or departmental priorities.

TRAVEL:

No more than 25%

The Clinical Trials Project Manager will develop, implement and manage all aspects of clinical trials in domestic and international countries for our clients. In addition, the Clinical Trials Project Manager will provide training to clients and internal staff. This is a full-time position.

Overall Responsibilities:

• Responsible for all data management tasks from study start-up through database lock. This includes database design, development of data management documents, and development of CRFs/eCRFs.
• Meet internal and external (Sponsor) deadlines and requirements according to time, quality, scope, and budget parameters.
• Ensures all data is accurate by programming edit checks, data cleaning, and generating and managing queries.
• Provide training support to clients and study staff on Electronic Data Capture (EDC) usage.
• Partner with the other functional groups (e.g., Biostatistics, Statistical Programming, Medical Writing, etc.) to ensure data management aspects of the project are properly considered and integrate well with the other activities
• Support the team with ongoing project work, as determined by business need
• Experience in project management roles, particularly in clinical data management, operations or project leadership role
• Up to 10% travel may be required.

Data Mangement

• Develop and/or review case report forms (CRFs) within EDC system.
• Author SOPs and WIs related to data management activities and the needs of the client, including the Data Management Plan, Data Transfer Plan, and Data Validation Plan.
• Lead all data cleaning activities, including data review and query generation and management.
• Aid in SAE reconciliation and reconciliation of external data (e.g. Core Lab).
• Ensure all medical coding is performed in a timely manner.
• Lead all database lock activities.

EDC Management

• Maintain close working relationship with software vendor.
• Build study database, program queries and edit checks.
• Liaise between study personnel and the client, as appropriate, regarding clinical and/or technical issues.
• Provide training support to clients and study staff on EDC usage.

Data Reporting and Analysis

• Produce study status reports, data tables, listings, or other outputs as required throughout the course of the project.
• Work with the Biostatistician in development of the Statistical Analysis Plan.

Education & Professional Experience:

• Bachelor’s Degree or higher in a related field, such as clinical/science fields
• Three (+) years of professional experience in clinical data management best practices, managing, cleaning and integrating large, complex databases and in health information systems and informatics standards
• 3 – 5 years’ experience in Health Data Analysis/Management, Statistics, FDA regulation clinical studies, and/or Public Health (Epidemiology/Biostatistics Focus) a plus.
• Excellent interpersonal, communication, and organizational skills with the ability to work both independently and in a team environment.
• Working knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
• Strong working technical skills, including Microsoft Office, EDC platforms, and programming languages. Ability to learn new applications.

Interested? Send your resume with the position of interest in the subject to employment@rqmis.com

The Regulatory Affairs Project Manager will work with our consultants and clients in supporting projects involving the collection of clinical data in either phase I, II, III or IV clinical studies. In addition, the Regulatory Affairs Project Manager will provide training to clients and internal staff. This is a full-time position.

OVERALL RESPONSIBILITIES:

Provide overall management of FDA and EU regulatory strategy and submissions for clients to assure development and execution of regulatory strategies that achieve expeditious market introduction in compliance with all relevant domestic and international regulations.

POSITION DUTIES & RESPONSIBILITIES:

Develop and implement efficient and effective regulatory strategies to bring products to market (domestic or international). All strategies must assure compliance to relevant regulations and standards for the intended market.

Responsible for the timely completion of the following activities:

• Design and manage testing of medical products to satisfy regulatory requirements
• Marketing submissions (510(k)’s, PMAs, CE Product Certifications, Design Dossiers, International Licenses, etc.)
• Creation and maintenance of Technical Files
• Review and approval of Labeling, Marketing, Sales Advertising and Promotional materials
• Identifying relevant standards for product development and manufacturing
• Review of Design History File to ensure Regulatory Compliance
• Interactions with representatives of U.S. and International Governmental Agencies and Notified Bodies
• Defining design control regulatory requirements for domestic and international markets
• Review and approval of Engineering Change Orders (ECOs)
• Assure positive relationship with U.S. and International Government Agencies and Notified Bodies
• Assure all communications with U.S. and International Government Agencies and Notified Bodies are documented and available for future reference
• Develop overall project plans for domestic and international submissions
• Assure all regulatory documents are complete and accurate
• Stay abreast of domestic and international regulatory requirements and standards
• Write departmental procedures and participate in training programs
• Design and conduct Training in areas of Good Engineering Practices, Protocol Design, Use of Statistical Techniques, Design Controls, Product Validation, Risk Management, Regulatory Requirements/Submissions, and so on
• Support special projects and other regulatory initiatives as assigned by management

EDUCATION & PROFESSIONAL EXPERIENCE:

• Bachelor’s degree in engineering or science field, or similar work experience
• 5 to 10 years experience in medical device, drug and/or biologics regulations (including premarket submissions for domestic and international markets)
• Previous supervisory or team leadership experience
• Knowledge of domestic and international medical device, drug and/or biologics regulations
• Strong attention to detail
• Strong computer skills, including word processing, spreadsheet and data programs
• Good oral and written communication skills
• Good leadership skills
• Ability to effectively manage multiple tasks while continuously assessing company and departmental priorities

Interested? Send your resume with the position of interest in the subject to employment@rqmis.com