Join Our Team of FDA Experts

EMMA International uses consultants for a variety of different projects and we are always looking for consultants to be considered for new projects. To become a consultant, fill out the consultant questionnaire.

Full-Time (On-Site)

Bingham Farms, MI

 Company Overview

EMMA International Consulting Group, Inc. is a global leader in management consulting services, with headquarters in Bingham Farms, Michigan.  We focus on quality, regulatory, and compliance services for the Biotechnology, Pharmaceuticals, and Medical Device industries.

Position Summary

Responsible for the development, maintenance, and implementation of specifications and standards for processes, materials, and products in accordance with quality programs, plans, SOPs and policies of the company’s Quality System and in compliance with FDA regulations, ISO 13485, and other regulatory requirements as applicable.

 Essential Duties

• Assist in the development, implementation, and maintenance of Quality System specifications and requirements in accordance with cGMPs, ISO 13485 and other International regulations as applicable.
• Direct and/or participate in projects directed at the development and implementation of quality standards throughout the company.
• Participate in department meetings to provide input into the design and implementation of product specifications.
• Write, review and edit documents and SOPs as required.
• Assist during FDA inspections, ISO Certification and surveillance audits and customer and supplier audits.
• Assist in validation activities and development of requirements and specifications.
• Follow-up on corrective action responses, ensuring implementation of appropriate problem resolution methods and verifying effectiveness.
• Facilitates problem-solving activities, team building and quality systems tools and methodologies.
• Collaborate with other departments and functions on continuous improvement opportunities of the Quality System.
• Carry out other duties as required or assigned.

Qualifications

• Experience developing and implementing quality plans and programs. ASQ certification (CQE, CRE) is preferred. Working knowledge and experience of FDA’s Quality System requirements (QSR), ISO 9001 and ISO 13485 standards. Ability to coordinate multiple project schedules and activities.
• The candidate should have strong analytical, communication and interpersonal skills. Strong linguistic, grammar, and editing skills. Ability to multi-task in an environment with changing priorities. Strong statistical training, skills and experience.
• Proficiency with Microsoft applications Word, Excel, Project, Visio, and PowerPoint. And ability to learn additional software applications, as the need arises.
• This is not an exhaustive list of qualifications

Education

BS or MS degree in technical/scientific/engineering discipline, with at least 2+ years of experience in medical devices, in vitro diagnostics or a related industry.

Working Conditions

• The work will be performed in an office environment.
• Minimal physical effort will be required in this position.
• Work days: Monday – Friday, 8:00 a.m. – 5:00 p.m.

Full-Time (On-Site)

Bingham Farms, MI

 Company Overview

EMMA International Consulting Group, Inc. is a global leader in management consulting services, with headquarters in Bingham Farms, Michigan.  We focus on quality, regulatory, and compliance services for the Biotechnology, Pharmaceuticals, and Medical Device industries.

Position Summary

As a Regulatory Scientist, you are responsible and accountable for developing and executing sound strategies for regulatory activities for new products. You will interact with clients to ensure the timely preparation of organized and scientifically valid applications to regulatory bodies.    

 Essential Duties

• Develop regulatory strategies for moderately to highly complex submissions to FDA and other regulatory authorities. Ensure timely submissions and approvals of pre-market submissions and marketing applications.
• Act as a liaison between clients and regulatory authorities regarding submissions.
• Interpret statutes, regulations, policies and guidance documents for business teams and product development/support teams, communicating how these impact product development, manufacturing, and/or marketing.
• Remain current on regulatory issues/trends affecting business unit products; assessing and communicating their impact to regulatory affairs colleagues, product development/support teams, and to others in the business.
• Develop, implement, and maintain departmental Standard Operating Procedures (SOP’s).
• Provide expertise in translating regulatory requirements into training documents.
• Other duties as assigned.

Qualifications

• 5+ years experience in the biotechnology, pharmaceutical, or other FDA-regulated industry.
• Demonstrated knowledge and application of regulatory requirements, international standards, and regulatory science.
• Demonstrated experience in interfacing with regulatory authority review staff and inspectors.
• Demonstrate strong project management, writing, and customer service skills.
• This is not an exhaustive list of qualifications

Education

MS degree or PhD in technical/scientific/engineering discipline, with at least 2+ years of experience in medical devices, in vitro diagnostics or a related industry.

Working Conditions

• The work will be performed in an office environment.
• Minimal physical effort will be required in this position.
• Work days: Monday – Friday, 8:00 a.m. – 5:00 p.m.