Join our RQMIS team

Career Opportunities at RQMIS

Our Mission

RQMIS’ mission is to bring about safe and effective medical devices and biotechnology products by assisting companies in navigating the regulatory process and addressing governmental requirements using the most efficient and effective processes during the premarket and post-market product phases. We provide all of our employees with equal opportunities for advancement, good working conditions, while paying competitive wages.

Opportunities

RQMIS offers a comprehensive benefits package to the people who work for and support the mission of RQMIS Inc. In an effort to provide exceptional customer service to all our clients, we are seeking qualified individuals who fit the specifications detailed in the open positions below.
Interested applicants, please submit your resume to employment@rqmis.com for consideration. If you're interested in working for the company but do not see an applicable position listed below, please send us your resume as we are always looking for great candidates to join our team!

Clinical Database Manager

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 Management

  • 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

Regulatory Affairs (FDA and EU) Project Manager

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

Technical Writer

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 3rd. yr. – 4th. 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

Equal Opportunity

RQMIS provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or other protected classes or characteristics protected by applicable law. Equal employment opportunity applies to all terms and conditions of employment including hiring, placement, promotion, termination, layoff, recall, transfer, leave of absence, compensation, and training.
RQMIS expressly prohibits any form of unlawful employee harassment or discrimination based on any of the characteristics mentioned above. Improper interference with the ability of other employees to perform their expected job duties is absolutely not tolerated.

RQMIS will provide equal opportunities in employment, promotion, wages, benefits and all other privileges, terms and conditions of employment. All recruiting, hiring, training, and promoting for all job classifications is done without regard to any of the characteristics mentioned above, except when a bonafide occupational qualification exist. All decisions on employment are made to further the principle of equal employment. All promotion decisions will continue to be made in accordance with Equal Employment Opportunity principles and only valid job requirements will be used.

Americans with Disabilities Act (ADA) and Reasonable Accommodation

To ensure equal employment opportunities to qualified individuals with a disability, RQMIS will make reasonable accommodations for the known disability of an otherwise qualified individual unless undue hardship on the operation of the business would result.

Commitment to Diversity

RQMIS is committed to creating and maintaining a workplace in which all employees have an opportunity to participate and contribute to the success of the business and are valued for their skills, experience, and unique perspectives. This commitment is embodied in company policy, the way we do business at RQMIS, and is an important principle of sound business management.