Open Positions

Mittal Consulting is always looking for passionate personalities who can contribute their experience and holistic view of the regulatory industry to deliver exceptional services to our clients. At Mittal Consulting you’ll gain diverse regulatory experiences and guidance needed to help you grow in the industry. We hire on a rolling basis, feel free to send your resume if you are interested in working at Mittal Consulting.

Why Work For Us?

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Flexible Hours

Life happens. With global clientele, all employees set their own flexible schedule based on availability.

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Fully Remote

All positions at Mittal Consulting are fully remote within the USA.
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New Innovative Technologies in MedTech

No ideas are bad ideas, all opinions count. We are here to innovate and promote groundbreaking ideas for newer technologies.

We Are Looking For:

Regulatory Affairs Intern- Med Device- CLOSED

Job Description

 

We have a vision of a world where people globally have access to a wide range of safe and effective medical devices which is made possible by accurate and timely regulatory support for our clients. With ever changing guidelines throughout the world, it has become increasingly complicated to get a novel device approved for sale globally. For this to change, our clients need expert and trustable guidance with a quick turnaround. We are a company built on a foundation of challenging the status quo of how both employees and clients work together and grow efficiently by providing the highest level of customer satisfaction and success.

Mittal Consulting is seeking a Regulatory Affairs intern to help build regulatory process tools and assist with our workload of upcoming projects. We’re looking for someone to quickly embed themselves in the industry, showcase an entrepreneurial candor and develop a strong regulatory work ethic.

**If you are looking for a foot in the door for the Regulatory world- this is your opportunity!**

 

Responsibilities

 

  • Learn about and gain a deep understanding of FDA and global regulations for medical devices
  • Assist in building regulatory training modules using the latest guidance
  • Help develop process flows for common types of FDA submissions
  • Assist in the compilation of tech files/ design dossiers to notified bodies under the new EU MDR regulations
  • Help in preparation of PMA, 180 DS, RTR, 30 DN, 510(k) and De Novo submissions to the FDA
  • Ensure FDA Readiness of technical documents by checking that they are complete and accurate
  • Perform quality control (QC) review of regulatory submission documents, i.e., grammatical/spelling, formatting, flow and language and general clarity of text
  • Verify that documents meet all applicable regulatory submission standards
  • Maintain product submission planners, submission timelines, and logs
  • Recommend enhancements to company procedures in response to changes in regulations or standards or to increase process efficiency

 

Position Requirements & Experience

 

  • A minimum of a Bachelor’s and or undergraduate degree in biological, chemical, engineering, regulatory sciences or writing and communication is required
  • Willingness to learn and having an open mind to figure out problem given the resources available
  • Ability to work independently with limited oversight
  • Proficiency in Adobe, Microsoft Suite
  • Knowledge of EU and FDA regulations is preferred
  • Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
  • Ability to work independently and as part of a team

 

Work Environment and Details

 

  • Remote position (Headquarter is in Portland, Oregon)
  • Flexible Hours (10-30 hours+- per week starting out with ability to increase hours as desired)
  • 1099 contract position
  • Contractor to provide their own office supplies including laptop
  • Work specific software licenses will be provided (Email, Zoom, Microsoft, CRM etc as required)
  • Travel will be reimbursed as required

Med Device Sr Regulatory Affairs Consultant- CLOSED

Mittal Consulting LLC is seeking a Sr Regulatory Affairs Consultant for an upcoming pipeline of work in the Medical Device industry. We’re looking for someone to quickly embed themselves with our clients and make an impact with their technical and professional expertise.
Responsibilities:
  • Class II and III Medical Device Submissions.
  • Prepare and submit PMA, 180 DS, RTR, 30 DN, 510(k) and De Novo submissions to the FDA.
  • Compilation and submission of tech files/ design dossiers to notified bodies under new EU MDR regulations.
  • Perform quality control (QC) review of regulatory submission documents, i.e., grammatical/spelling, formatting, flow and language and general clarity of text.
  • Verify that documents meet all applicable regulatory submission standards product submission planners, submission timelines, and submission logs.
  • Work with clients to determine classification and regulatory pathways for US, EU, and other international markets.
  • Manage multiple, parallel projects to successful completion.
Position Requirements & Experience:
  • A minimum of a Bachelor’s and or undergraduate degree in biological, chemical, engineering or equivalent regulatory sciences is required.
  • Knowledge of EU and FDA regulations is required. 5+ years of Experience in filing regulatory submissions from early development to pre and post approval submissions and product lifecycle management is preferred.
  • Experience with PMAs is required.
  • Client centered focus and problem solving skills.
  • Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
  • Ability to work independently and as part of a team.
Minimum 5 years of related regulatory experience, including:
  • Writing and submitting at least one FDA regulatory submission in the past year.
  • Writing at least one EU MDR or IVDR Technical File in the past year.
  • Writing at least one new product introduction regulatory strategy.
  • Experience with submitting Pre-Submission meeting requests into the FDA and participating in those meetings.
  • Experience with assessing device changes for regulatory notification device labeling including UDI
Email resumes to careers@mittalconsulting.com

Global Marketing Specialist- CLOSED

Job Description: Global Marketing Specialist

We have a vision of a world where people globally have access to a wide range of safe and effective medical devices which is made possible by accurate and timely regulatory support for our clients. With ever changing guidelines throughout the world, it has become increasingly complicated to get a novel device approved for sale globally. For this to change, our clients need expert and trustable guidance with a quick turnaround. We are a company built on a foundation of challenging the status quo of how both employees and clients work together and grow efficiently by providing the highest level of customer satisfaction and success.

In this role the Global Marketing Specialist to help build marketing process tools and assist with our workload of upcoming projects. They will quickly embed themselves in the industry, showcase entrepreneurial candor and develop a strong marketing strategy for global outreach.

Responsibilities

  • Work closely with CMO to achieve success on specific marketing goals spread across each quarter.
  • Learn and gain a deep understanding of the Mittal Consulting marketing initiatives and develop a plan for global outreach.
  • Work strategically with each marketing vertical to create demand, enable sales, increase awareness, and drive client success.
  • Plan and execute integrated marketing campaigns across multiple channels, including digital marketing, social media, email, events, and more.
  • Work with our industry partners for shared marketing initiatives.
  • Research, organize, and attend conferences including booth setup, look for speaker opportunities or panel discussions.
  • Create and enhance marketing materials, thought libraries, and promote media and content on social platforms like LinkedIn.
  • Maintain website content.
  • Utilize experience and industry trends to define and revise marketing approach.
  • Recommend enhancements to company procedures in response to changes in regulations or standards or to increase process efficiency.

 

Position Requirements & Experience

  • A minimum of a bachelor’s and or undergraduate degree in biological, chemical, engineering, marketing, and/or communication is required.
  • 2-3 years’ experience in relevant field
  • Willingness to learn and having an open mind to figure out problem given the resources available for a small consulting company.
  • Ability to work independently with limited oversight.
  • Proficiency in Adobe, Microsoft Suite, Smartsheets, Canva, LinkedIn.
  • Knowledge of EU and FDA regulations is preferred.
  • Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.

Work Environment and Details

  • Remote position (Headquarter is in Portland, Oregon).
  • Flexible Hours (up to 20 hours per week starting out).
  • 1099 contract position.
  • Contractor to provide their own office supplies including laptop.
  • Work specific software licenses will be provided (Email, Zoom, Microsoft, CRM etc as required)
  • Some travel required (<10%).
  • Travel will be reimbursed.
Email resumes to careers@mittalconsulting.com