Regulatory Specialist II

Job Description

Job Summary:

• The initial phase of the role will focus on structured training to familiarize the candidate with internal systems, processes, and procedures.
• Once training is completed, the primary responsibility will involve archiving regulatory submissions to help address existing backlog.
• Upon successful completion of this phase, the individual will gradually transition into broader responsibilities aligned with the core functions of the Regulatory Specialist role.
• The selected candidate will be part of a team of approximately 12 professionals and will work closely with a smaller group of 2–3 regulatory specialists.

Job Summary:

• Responsible for Regulatory Affairs support of submissions and on going regulatory compliance for product development process.

Duties and Responsibilities:

• Under minimal supervision, acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
• Assists with developing and implementing regulatory strategies for new and modified medical devices.
• Acts as a core team member on development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.
• Responsible for preparation and submission of regulatory applications, as well as internal regulatory file documentation.
• Reviews device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes.
• Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.

Quality Systems Requirements:

• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• For those individuals that supervise others, the following statements are applicable:
• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Client Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Required Qualifications:

• BS degree and 2-4 years of related experience, or MS degree and 0-2 years of related experience.
• Demonstrated background in regulatory affairs (required).
• Proficiency in Microsoft Office suite.
• Experience working with regulatory management systems used for archiving and managing submissions; this will be a primary focus area of the role.
• Strong written and verbal communication skills, with the ability to collaborate across multiple departments.
• Ability to work independently in a minimally supervised environment; must be proactive in seeking guidance when needed.
• Team-oriented mindset with a collaborative approach.
• Must have a dedicated, professional home office environment with reliable internet connectivity to support remote work responsibilities.
• Candidates with medical writing backgrounds will not be considered for this position.

Preferred Qualifications:

• Master’s degree in Regulatory Affairs with 0–2 years of related experience.
• Experience using Windchill.