Regulatory Affairs Specialist

4 weeks ago

Boston, United States Myomo, Inc. Full time

Have you ever felt blown away by the miracles of modern medicine, while also feeling that the patient experience still leaves much to be desired?


Here at Myomo, Inc., it's our mission not only to leverage the power of cutting-edge robotic technology to improve patient quality of life, but also to demonstrate a commitment to prioritize and serve the patient.


We are 1st in the U.S. to develop and market the MyoPro® product line of lightweight, non-invasive, powered arm braces (orthoses) to restore function in the paralyzed or weakened arms and hands of individuals that have suffered a stroke, spinal cord or nerve injury such as brachial plexus injury, or other neuro-muscular disability such as traumatic brain injury, (TBI) brachial plexus injury, (BPI) or multiple sclerosis (MS). It is the only device that, sensing a patient’s own neurological signals through non-invasive sensors on the arm, can restore their ability to use their arms and hands so that they can return to work, live independently and reduce their cost of care.


At Myomo, we are driven by a mission to enable independence and confidence for stroke survivors as well as those living with the impact of another neurological disorder. Our teams continue to break through barriers, defining the limits of what is possible in both medical device robotics and our global system of care.


We're currently seeking a strong Regulatory Affairs Specialist, (RAS) who will work to ensure that company products and processes comply with all applicable regulations and standards.


The ideal candidate is collaborative with strong communication and problem-solving, as well as project/time management skills. He/she holds previous regulatory compliance background as well as an appreciation for consistency. He/she will demonstrate strong attention to detail as well as the capability to thrive in an evolving environment, all while driving back to processes and procedures.


Responsibilities

  • Research, understand, and propose updates according to applicable laws and standards.
  • Assist with the development or enhancement of compliance policies, procedures, or protocols necessary to support operations.
  • Train employees, providing guidance and mentorship to associate staff relating to regulatory matters.
  • Create, maintain, and track records and regulatory files as appropriate.
  • Assess compliance, review, documentation, and report on status in accordance with needs.
  • Ensure preparation for external audits, conducting and/or implementing internal audits where appropriate.
  • Advocate and represent company interests, providing feedback to government agencies and/or industry associations on proposed regulations when appropriate.
  • Establish and improve new processes, identify organizational risks, and support process improvements where necessary.
  • Conduct product registrations, renewals, and submissions.
  • Facilitate completion of regulatory tasks pertaining to various products, both in US and International divisions.
  • Assure fully compliant UDI labeling, database entry, codes, and user manuals.
  • Assist Quality & Regulatory with overall compliance as well as other related projects as needed.


Requirements

  • Bachelor’s or equivalent in Regulatory Affairs or related Science, along with 5+ years' experience in a related industry.
  • Experience in Quality Management System (QMS) applications.
  • Knowledge of regulatory websites, software or functions, and use thereof.
  • 3+ years' experience within the medical device industry.


Preferred:

  • Bachelor’s or Master’s in Regulatory Affairs.
  • Regulatory Affairs Certification. (RAC)
  • Experience in product FDA submissions.
  • Certified Quality Auditor. (CQA)
  • Knowledge of ISO or MDSAP.
  • International product registrations.
  • Supplier and contractor audits and qualifications.

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