Join Our Team

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)

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 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 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