Regulatory Associate Fda

**ESSENTIAL FUNCTIONS**:
The Regulatory Associate role has three levels: I, II, and III.

All Regulatory Associates I, II, and III:

- Understand and maintain the company's file structures and locations for controlled documents and the Regulatory drive.
- Complete all assigned quality management system training on schedule.
- Prepare attachments and hyperlinks for submissions to regulatory agencies, notified body, competent authorities, and/or authorised representative.
- Provide audit support in the audit backroom.
- Support internal and external audits and compliance assessments.
- Provide regulatory feedback and guidance based on medical device regulations and standards to the company throughout the development cycle.
- Attend labs where technology under development is being tested to gain more understanding of how the technology is being used.
- Locate all regulatory certificates.
- Independently generate document change requests as needed.
- Understand the commercial release authorisation process and update commercial release authorisations as directed.
- Process complaint intake as a backup to the complaint coordinator as needed.
- Perform all other responsibilities as assigned.

Additionally, All Regulatory Associates II and III:

- Monitor regulations, standards, policies, and guidance for new and current compliance requirements that may have impact to the company.
- Conduct gap assessments.
- Maintain full quality and regulatory compliance with all standards that govern the design, development, manufacturing, and distribution of the company's medical devices.
- Process complaints through our complaint system as a backup to the complaint coordinator as needed.
- Search the MAUDE database for adverse events.
- Process complaint device return and tracking as a backup to the complaint coordinator as needed.

Additionally, All Regulatory Associates III:

- Lead regulatory training sessions for other teams (inter-team).
- Successfully participate in CAPA investigations.
- Conduct CAPA verification of effectiveness.
- Understand the company's BOM structure and can trace related work instructions, process flow diagrams, process control plans, and inspection plans.
- File MedWatch adverse event reports as a backup to the complaint coordinator as needed.
- File foreign adverse event reports as a backup to the complaint coordinator as needed.
- Complete complaint trend reports.
- Collaborate with Operations to become familiar with all manufacturing processes used at the company's.
- Participate on product development teams by providing assessment of proposed changes, regulatory strategy, time-lines, and deliverables ensuring proper governing requirements are incorporated as part of the development process.
- Independently Complete Change Control Board intake forms.
- Complete Change Control Board analysis and risk assessments with mentoring.

**EDUCATION & EXPERIENCE**:
Regulatory Associate I:

- Bachelor or Master's degree in a technical, regulatory, or life sciences discipline with 0-2 years' experience in FDA regulated environment (medical devices preferred).

Regulatory Associate II:

- Bachelor or Master's degree in a technical, regulatory, or life sciences discipline with 1-2 years' experience, relevant to the Regulatory Associate II Essential Functions listed above, in an FDA regulated environment (medical devices preferred).

Regulatory Associate III:

- Bachelor or Master's degree in technical, regulatory, or life sciences discipline with 2-3 years' experience, relevant to the Regulatory Associate III Essential Functions listed above, in an FDA regulated environment (medical devices preferred).
- Regulatory Affairs Certification (RAC) a plus, but not required.

**KNOWLEDGE, SKILLS & ABILITIES**:

- Effectively manage time and resources.
- Excellent verbal and written communication skills.
- Team oriented worker.
- Customer-focused, goal-oriented self-starter.
- Requires strong attention to detail and excellent follow-up skills.
- Basic understanding of FDA Quality System Regulation.
- Basic understanding of ISO 13485.
- If assigned to the European Regulatory Team, a basic understanding of European Medical Device Regulation.
- If assigned to the Rest of World Regulatory Team, a basic understanding of international regulatory fundamentals for medical devices.
- Proficient with various computer programs including MS Office..