Associate Regulatory Affairs Consultant

  • Full Time
  • Anywhere
  • Full Time
  • Anywhere

Medical Device Academy, Inc.

Building sustainable businesses for content creators

The associate regulatory consultant will work under the direct supervision of a more experienced regulatory consultant and receive training from multiple people within the company. This person will work with various medical device company clients to prepare regulatory submissions for various international markets. The consultant may also support Quality Management System implementation and training. Consultants may sometimes serve supporting roles in client company QMS operations, typically in the areas of CAPAs, Complaints, Mandatory Reporting, Recalls, etc.

 

You will be responsible for the following activities:

  • Identifying the regulatory pathway for a medical device (USA, Canada and Europe)
  • Preparation of classification rationales
  • Preparation of draft testing plans
  • Preparation of pre-submission meeting requests
  • Preparation of regulatory submissions, such as: 510(k), De Novo, Canadian License, and CE Marking TF

The associate regulatory consultant will NOT be responsible for the following:

  • Preparing regulatory or quality system documentation without any review or input from an experienced regulatory consultant or quality system consultant on our team
  • Leading teleconference meetings with regulators (FDA, Health Canada, or NB), unless their supervisor has prepared them for this and their supervisor is also involved in that call
  • Preparing proposals or invoices for clients

The associate regulatory consultant may have experience in one of our three primary markets (i.e. USA, Europe, or Canada), but we expect there to be gaps in your training. Our firm specializes in training people on QA and RA requirements for all three markets. Therefore, we have dozens of recorded webinars available on-demand for you to take at no cost. Any self-training should be planned with the direct supervisor, documented in Asana, and training records should be created–including corrected quizzes whenever possible. We encourage associate regulatory consultants to recommend improvements to our training content, and to take the initiative to make corrections and work with an experienced consultant to record updated webinars with updated quizzes whenever possible.

 

An associate regulatory consultant should have exceptional oral and written communication skills. Consultants must listen well and be able to effectively communicate with regulators, clients, and our team. They must be extremely competent with remote communication software tools (phone and video conferencing), organization, and self-motivation. Prior experience with medical device start-up companies is a huge plus. 100% of our customers are small medical device companies, and many do not have adequate experience or prior training. Patience with clients is paramount. The goal is to have clients that are so thrilled with your service, that they will become your raving fan and refer future clients to work with you. The ability to most efficiently navigate the appropriate regulatory pathway will ensure customer satisfaction. Accurately estimating the duration of the associated tasks and scopes of projects along with clear and honest communication regarding potential risks and hurdles associated with their device and regulatory strategy is extremely important. Despite balancing multiple clients and projects, the goal is to make each client feel like they are your most important client. Communication and openness is key to achieving this objective. Outstanding service is an expectation at Medical Device Academy, which has even resulted in consultants receiving $ tips for outstanding service (its happened twice in our company).

 

Work Environment

All employees work from home. If you need to purchase any office furniture to establish a suitable work environment, you will be reimbursed for those purchases. If you choose to sublease office space instead of working from home, we can discuss reimbursement of a reasonable office lease or potentially sign and pay the lease agreement for you.

Video Interview with Hiring Manager

Rob Packard and Sharon Morrow recorded a 10-minute interview describing the position. As you can see from the video, they are both working from home and a large portion of their time is spent with consulting clients in Zoom meetings.

 

 


 

We are a small consulting firm providing medical device companies with regulatory and quality system services and training. We have 7 full-time employees and 1 part-time employee. We are hiring for an 8th full-time employee. We specialize in medical device 510k submissions. We even wrote a 510k book, “How to prepare your 510k in 100 days,” because 100 days is how long your testing will take. We are affordable because we know you start-ups have “one egg and one basket.” We are casual. We like taking risks. We are irreverent. We make mistakes, but we learn from them. We want our work to be fascinating. We teach the most boring topic on planet earth, but we refuse to be boring. After all, no other regulatory consultants would write a book titled “Plague Doctor’s Scary Guide to Remarkable Remote Quality Audits.” We want to be remarkable, memorable, and fun to work with. Our team is located in Washington DC, Kansas, and Vermont. We all work 100% remotely, and we always have. A button for downloading our standard pricing sheet for all services is provided below.

Tagged as: QA, Technical Writing, Usability Testing

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  • Begin your application by clicking the Apply button below, and be sure to reference Incluzion as a source while applying.
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  • Spread the word about Incluzion!

Incluzion acts as your personal reference for your application, so let us know when you apply!


  • Begin your application by clicking the Apply button below, and be sure to reference Incluzion as a source while applying.
  • If you have not done so, add your resume to the Incluzion talent database to ensure you're connected with similar opportunities
  • Spread the word about Incluzion!

Contact us

Medical Device Academy, Inc.

Building sustainable businesses for content creators

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