Nov 17, 2021

Regulatory Affairs Specialist

  • NICO Corporation
  • Remote (Indianapolis, IN, USA)
Full time Quality Regulatory

Job Description

Job Description:

The primary focus of the Regulatory Affairs Specialist is to work closely with Quality and Engineering on the development, management and maintenance of regulatory-related registrations and processes for NICO’s products, and to participate and/or support in the development of new products.

Responsibilities are, but not limited to the following:

  • Preparing and/or managing the outsourcing of regulatory documentation for NICO’s products, including technical documentation, device licenses, 510k submissions, etc.
  • Management of international registrations for NICO’s products (Canada, Australia, Europe, UK, Japan, etc.)
  • Assessment of Regulatory requirements within new potential markets
  • Writing and/or outsourcing the writing of Clinical Evaluation Reports in accordance with MEDDEV 2.7/1 rev 4, and Post-Market Clinical Follow-Up Report in accordance with MEDDEV 2.12/2 rev 2.
  • Developing, supporting and executing regulatory plans and strategies, including prioritization, timelines and budgeting (e.g., EU MDR & UKCA)
  • Must develop a familiarity and a technical understanding of NICO’s products and their associated design history file documentation (design controls, verification and validation protocols, etc.)
  • Management of international post-market surveillance activities for all NICO products
  • Familiarity with Quality Management Systems within a medical device setting, including ISO 13485, FDA QSR, CMDCAS/MDSAP, etc.
  • Reviewing and interpreting regulatory rules and ensuring they are communicated throughout company policies and procedures
  • Develop and/or review product labeling to ensure compliance with regulatory requirements
  • Support NICO’s QMS as needed (e.g., international complaint handling)
  • Assist with the execution of a product development process that ensures the effective commercialization of new products for NICO
  • Assist with strategy, development, execution, and project management of clinical studies as assigned.

 

Hard Skills:

  • Minimum of a bachelor’s degree from a recognized educational institution
  • 3 - 5 years minimum experience in regulatory affairs for medical devices
  • Familiarity with ISO 13485, FDA 21 CFR, MDSAP, EU MDR and/or other regulations or standards specific to medical devices
  • Successful track record of managing results
  • Demonstrated success in delivering results in a fast paced, growing company
  • Sets deadlines and other work objectives and works rigorously to meet them
  • Must be highly proficient in the use of computer systems and software programs such as Microsoft Word, Excel, PowerPoint, Project, etc.

 

Soft Skills

  • Must be well organized and process oriented
  • Ability to lead by example
  • Ability to interact with others effectively
  • Ability to influence within an organization
  • Demonstrates trustworthiness, respect, and integrity
  • A natural problem solver who is proactive
  • Committed to success through effective teamwork and communication
  • Creative and forward thinking in terms of new regulatory approaches
  • Ability to maintain confidentiality, show respect for others, and work as an integral member of company
  • Effective and persuasive written skills
  • Works well with product marketing, finance, field sales, clinical applications, quality, and operations

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