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!

Regulatory Affairs III Associate

The Regulatory Affairs III Associate professional integrates regulatory knowledge throughout the product lifecycle with aspects of effective management and strategy development. This level represents the move from the technical and tactical dimensions of RA and the product lifecycle into a more strategic role.

OVERALL RESPONSIBILITIES:

Strategic Planning

  • Evaluate regulatory risks of corporate policies
  • Recruit, manage, develop and mentor regulatory professionals
  • Develop new regulatory policies, procedures and SOPs and train key personnel on them
  • Assist in the development and advancement of policy and procedures for regulatory affairs and compliance to establish a compliant culture within the organization
  • Utilize technical regulatory skills to propose strategies on complex issues
  • Monitor emerging issues and identify solutions
  • Monitor trade association positions for impact on company products
  • Provide regulatory input to product lifecycle planning
  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
  • Evaluate the effect of regulatory requirements on product positions
  • Assist in the development of global, regional and multicounty regulatory strategy and update strategy based upon regulatory changes
  • Determine submission and approval requirements
  • Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
  • Assist in regulatory due diligence

Premarketing

  • Provide strategic input and technical guidance on regulatory requirements to development teams
  • Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions
  • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
  • Manage and execute preapproval compliance activities
  • Assess the acceptability of quality, preclinical and clinical documentation for submission filing
  • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
  • Identify issues early in the submission preparation process that could impact product launch
  • Monitor impact of changing regulations on submission strategies and update internal stakeholders
  • Prepare regulatory submissions
  • Monitor and submit applicable reports and responses to regulatory authorities
  • Monitor applications under regulatory review
  • Propose risk-based decisions on special access approval with appropriate regulatory agencies to pursue approvals based on patient needs and risk assessment

Postmarketing

  • Maintain annual licenses, registrations, listings and patent information
  • Ensure compliance with product postmarketing approval requirements
  • Review and approve labeling to ensure compliance with regulations and company policy
  • Review and approve advertising and promotional items to ensure regulatory compliance
  • Assess external communications relative to regulations
  • Review publicly disseminated information to minimize regulatory exposure, review product claims and preserve confidentiality of applicable product information
  • Review and approve required reports, supplemental submissions and other postmarketing commitments to update and maintain product approvals and registrations
  • Provide regulatory input for and appropriate follow-up to inspections and audits
  • Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events
  • Submit/review change controls to determine the level of change and consequent submission requirements
  • Actively contribute to the development and functioning of the crisis/issue management program
  • Identify product-associated problems and develop proposals for solutions
  • Provide regulatory input for product recalls and recall communications
  • Manage system to ensure that product safety issues and product-associated events are reported to regulatory agencies
  • Report adverse events to regulatory agencies and internal stakeholders

Interfacing

  • Provide training for stakeholders on current and new regulatory requirements to ensure
  • company-wide compliance
  • Communicate regulatory agency/industry positions to internal stakeholders
  • Strategize with and advise internal stakeholders on regulatory issues
  • Communicate and negotiate with regulatory authorities and stakeholders
  • Conduct technical meetings with regulatory advisory committees and government agencies
  • Communicate the impact of new, existing and pending regulations, guidelines
  • and standards, and review committee recommendations to regulatory staff and internal stakeholders
  • Participate in medical/scientific review and other relevant committees
  • Accompany inspection team(s) as required
  • Notify, consult or brief legal counsel when appropriate
  • Participate and take leadership role in professional associations, industry/trade groups (local/regional/ international) and appropriate standards organizations

Requirements:
Bachelor’s degree or foreign equivalent in regulatory affairs, biomedical, mechanical, chemical, electrical, or biochemical engineering, chemistry, microbiology or a related field, plus three months of experience in the job offered or with medical, drug and/or biologics regulations, including premarket submissions for domestic and international markets.

Travel: No more than 20% at client sites nationwide.

Hours: 40/week, 9:00 a.m. – 5:30 p.m.

Location: 110 Haverhill Road, Suite 524, Amesbury, MA. 01913

Apply by resumes marked to:

Hiring Manager

Regulatory/Quality Management Information Source, Inc.

110 Haverhill Rd., Suite 524

Amesbury, MA 01913

978-358-7307

employment@rqmis.com

Sr. Quality Systems Analyst – Medical Device and Combination Products

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 process 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 leadership to RQMIS employees in the area of project management and quality systems. Support the development/ implementation/management of tools for RQMIS employees in performing their duties.

POSITION DUTIES & RESPONSIBILITIES:

  • Working knowledge of Medical Device and Combination Products
  • Assist and support client’s product development activities through interpretation and implementation of FDA’s GMPs, QSR, GTPs, ISO 9001, ISO 13485, and 21 CFR part 820 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.
  • Apply Design of Experiments (DOE) to process qualification/validation.
  • Design and implement IQ/OQ/PQ for client equipment and processes.
  • Audit client’s quality system to assure compliance to the FDA’s QSR, ISO 13485 and other regulatory/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, 21 CFR part 820, etc.
  • Assist in the development of CMC regulatory submissions for domestic and international markets

EDUCATION & PROFESSIONAL EXPERIENCE:

  • Bachelor’s degree in engineering/scientific field (biochemical engineer, biomedical engineer, pharmacist, chemist, biologist, microbiologist), or similar work experience
  • 6 to 10 years experience with drug, biologics, tissue regulations/standards (including premarket submissions for domestic and international markets)
  • Knowledge of domestic/international drug, biologics, tissue and combination product regulations/standards/guidances
  • 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 40%

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 promotion for all job classifications are done without regard to any of the characteristics mentioned above, except when a bonafide occupational qualification exists. 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, and the way we do business at RQMIS, and is an important principle of sound business management.