Careers

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

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

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