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.
- 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.
- 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