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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.

Check out the open positions below and apply to become part of the RQMIS family today!

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 are 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!

Junior Regulatory Affairs Consultant

We are looking for recent graduates who studied Chemistry/Science and want to get their foot in the door of the Regulatory world. This position gives a junior candidate the opportunity to develop a basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures. The Junior Regulatory Affairs Consultant will work in the Regulatory department with other more senior consultants and will be required to coordinate and support regulatory activities, communicate with clients, research and organize information for regulatory reports, maintain accurate records and adhere to strict deadlines. The individual must work well independently to meet milestones but also be able to work in a team as there will be multiple staff members working on each project.

POSITION DUTIES & RESPONSIBILITIES

Strategic Planning

  • Investigate regulatory history of similar products to assess approval implications
  • Conduct research on submission requirements and options
  • Assist in monitoring and reporting project timelines
  • Respond to RA information requests
  • Monitor and utilize tracking and control systems

Premarketing

  • Organize materials from preclinical and clinical studies
  • Collect and organize materials for Presubmission reports
  • Aid senior regulatory consultants with preparation of submission packages for regulatory agencies (ie. FDA, EU Notified Bodies, etc.)
  • Monitor status of applications under regulatory review
  • Organize meetings with regulatory agency staff

Post marketing

  • Update and maintain paper/electronic document archival systems
  • Assist in the preparation of routine reports and regulatory agency communications
  • Assist in the preparation of post market reports and submissions
  • Track product events, complaints and recalls

REQUIRED SKILLS

  • Regulatory Affairs knowledge a plus but NOT required
  • Project coordination/management
  • Strong oral and written communication skills (including writing and editing technical documents)
  • Analytical and critical thinking skills
  • Ability to work both independently and as a team member
  • Ability to prioritize/manage tasks effectively
  • Strong adherence to strict deadlines, and ability to communicate roadblocks to management as they occur
  • Strong research and organizational skills
  • Acute attention to detail
  • Familiarity with tasks related to Strategic Planning, Premarketing, Post marketing, and Interfacing a plus but not required
  • Experience with Mac computers, Microsoft Office 365 suite and Asana preferred but not required

EDUCATION & PROFESSIONAL EXPERIENCE

  • Bachelor’s degree in engineering/science field, or similar work experience
  • 0 to 2 years’ experience in medical device, drug and/or biologics regulations (including premarket submissions for domestic and international markets)

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

Quality System or Engineering Consultant

The Quality Systems or Engineering Consultant is to advise and implement quality systems for medical device manufacturers. This position requires utilization of Quality Management System methods, including but not limited to: quality system implementation, project management, design controls, validation (design, process, and/or software), risk management, design verification, and post-market activities. Must interact with consultants, clients, suppliers, and experts outside QA Consulting in order to communicate and implement QA Consulting’s objectives. This is a full-time position.

OVERALL RESPONSIBILITIES:

Consultant shall 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, and compliance. Provide support for the development, implementation, and management of tools for RQMIS employees in performing their duties.

Consultant shall demonstrate knowledge and skills in areas such as, but not limited to, regulatory pathways and options; documentation; risk-benefit analysis; communication and collaboration internally and externally; working with vendors and subcontractors; submission, registration, obtaining approval, documentation, compliance, post-market surveillance and vigilance; and distribution.

POSITION DUTIES & RESPONSIBILITIES:

  • Assist and support client’s product development activities through interpretation and implementation of FDA’s QSR, GTPs, ISO 9001, ISO 13485 requirements and other regulatory and standard requirements.
  • Assist in developing and maintaining client’s quality system procedures, CAPA process, inspection instructions, and related documentation in support of product development, production and post market activities.
  • Supply Design of Experiments (DOE) to process qualification and validation.
  • Design and implement IQ, OQ and PQ for client equipment and processes.
  • Audit client’s quality system to assure compliance to the FDA’s QSR, ISO 13485 and other regulatory and standards requirements.
  • Develop and implement tools for RQMIS employees in conducting their activities
  • Develop and execute training programs used to educate clients or potential clients on how to implement regulatory and standard requirements such as FDA’s QSR, GTPs, ISO 13485, ISO14971, etc.
  • Assist in the development of regulatory submissions for domestic and international markets
  • Assess the acceptability of quality, preclinical and clinical documentation for submission filing to comply with regulatory requirements for clinical trials, marketing applications and corporate goals, to secure submission approval
  • Identify issues early in the submission preparation process that could impact product launch
  • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
  • Ensure compliance with product post-marketing 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 regulatory issues
  • Communicate and negotiate with regulatory authorities and stakeholders

EDUCATION AND PROFESSIONAL EXPERIENCE:

  • Bachelor’s degree in engineering or technical field (biomedical, mechanical, chemical, electrical, biochemical engineer, microbiologist, etc.), or similar work experience
  • 4 to 6 years’ experience with medical device regulations and standards (including premarket submissions for domestic and international markets)
  • Knowledge of domestic and international medical device regulations, standards, and guidances
  • Strong attention to detail
  • Good oral and written communication 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

Equal Opportunity and Commitment to Diversity

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.