Careers

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 Technical Writer will work with our consultants/clients in supporting projects involving regulatory submissions, quality system documentation and/or clinical study material. In addition, the Technical Writer will provide training to clients and internal staff.

Overall Responsibilities:

Design, create and maintain technical documentation. Technical documentation includes product labeling, regulatory submissions, quality system procedures, forms, clinical study documentation, and so on.

Position Duties and Responsibilities:

Responsible for the timely completion of the following activities:

• Organize and publish material with required style, terminology, clarity and order
• Coordinate with Project Manager and client representatives to establish technical specifications required for publication
• Develop product documentation
• Develop regulatory submissions: 510(k), IDE, PMA, and so on
• Create and edit Quality System documentation (SOPs, Flowcharts, and so on)
• Create and maintain Technical Files
• Convert documentation as necessary
• Participate in other projects as needed
• Perform other duties as assigned

Education & Professional Experience:

• Bachelor’s Degree or in the process of attaining such a degree
• 0 – 1 years (current college students 3^rd. yr. – 4^th. yr. are encouraged to apply)
• Strong computer skills, including Word, Excel, Visio and Adobe Professional
• Excellent oral and written communication skills
• Experience creating technical documentation
• Ability to communicate technical concepts to a non-technical audience
• Ability to manage several tasks simultaneously

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

The Clinical Trials Project Manager will develop/implement/ 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 salaried position.

OVERALL RESPONSIBILITIES:

• Develop/implement/manage all aspects of clinical trials in domestic and international countries.
• Provide training to clients and internal staff on such areas as clinical trial management, good clinical practices (GCPs), FDA Biomonitoring, CRF design, clinical report writing, Clinical Study Monitoring, etc.

POSITION DUTIES & RESPONSIBILITIES:

• Manage all aspects of clinical projects
• Write departmental procedures and assist in training efforts
• Participate in special projects as needed
• Travel required (up to 30 to 50%)
• Other duties as assigned

EDUCATION & PROFESSIONAL EXPERIENCE:

• Bachelor’s degree in clinical/science field, or similar work experience
• 5 to 7 years experience in medical device clinical trials
• Previous supervisory or team leadership experience
• Knowledge of domestic/international medical device 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 manage several tasks simultaneously while continuously assessing company and/or departmental priorities