Top 113 Technical specialist Jobs in Naples, Fl

Regulatory Affairs Specialist I - Spine
Arthrex —Naples, FL
- Microsoft Excel
- Research
- Mid-level
- Paid parental leave
- Health insurance
3d
Safety Professional I
Gilbane —Naples, FL
- $64,000 - $78,000 a year
- Construction site
- Communication skills
- Entry level
- Profit sharing
- Health insurance
Account Cancellation Specialist
Line 5, LLC —Naples, FL
- Full-time
- Writing skills
- Mid-level
- Business development
Event Technical Specialist (Video) Part Time on call- Naples market
Encore Global —East Naples, FL
- $25.19 - $32.75 an hour
- Part-time
- Customer service
- Mid-level
- 3 years
Staffing Specialist / Recruiter
Vision Landscapes Florida —Bonita Springs, FL
- $27 - $32 an hour
- Full-time
- Background check
- Spanish
- Research
- Health insurance
- Dental insurance
Quick Apply
Lab Technologist Specialist
NCH —Naples, FL
- 8 hour shift
- Microsoft Excel
- Microsoft Outlook
- Computer literacy
Business Development & Sales Specialist
Continuum Services —Florida
- Full-time
- Microsoft Outlook
- Mid-level
- Business development
Safety Professional I
Gilbane Building Company —Naples, FL
- $64,000 - $78,000 a year
- Full-time
- Construction site
- Communication skills
- Entry level
- Profit sharing
- Health insurance
Technical Support Specialist
Rentvine —Estero, FL
- $50,000 - $55,000 a year
- Weekends as needed
- Mid-level
- Finance
- Bachelor's degree
18h
Accounts Payable Specialist I
Arthrex —Naples, FL
- Word processing
- Basic math
- Continuous improvement
- Paid parental leave
- Health insurance
Biocompatibility Specialist II
Arthrex —Naples, FL
- Microsoft Excel
- Bachelor of Science
- Mid-level
- Paid parental leave
- Health insurance
Seasonal, Operations Technical Specialist (Part Time)
H&R Block —Naples, FL
- Full-time
- Microsoft Outlook
- Mid-level
- Office
- Flexible schedule
Installation Project Specialist - Synergy
Arthrex —Naples, FL
- $73,500 - $100,000 a year
- Microsoft Excel
- Microsoft Outlook
- Maintenance
- Paid parental leave
- Health insurance
Travel Specialist II (2nd Shift - Hybrid 1 Day Onsite))
Arthrex —Naples, FL
- $24.25 - $38.00 an hour
- Extended hours
- Hybrid work
- Spanish
- Writing skills
- Basic math
- Paid parental leave
- Health insurance
Assets Protection Specialist
Target —Naples, FL
- $22.25 - $37.80 an hour
- Part-time
- 18 years or older
- High school diploma or GED
- Communication skills
- Paid holidays
- Disability insurance
4h
Procurement Specialist
Western Global Airlines —Estero, FL
- $55,000 a year
- Weekends as needed
- Mid-level
- Office
- Business Administration
Quick Apply
Clinical Sales Specialist, Electrophysiology - LAAO - Naples, FL
Abbott Laboratories —Naples, FL
- $68,000 - $136,000 a year
- Full-time
- 6 years
- Up to 50% travel
- Bachelor of Science
- Health insurance
- Tuition reimbursement
Lab Technologist Specialist
NCH Healthcare System —Naples, FL
- 8 hour shift
- Microsoft Excel
- Microsoft Outlook
- Computer literacy
Irrigation Specialist
Four Seasons —Naples, FL
- Full-time
- Schematics
- Computer literacy
- Mid-level
- Health insurance
- Dental insurance
ANNUAL GIVING SPECIALIST
AVOW FOUNDATION INC —Naples, FL
- $70,000 - $90,000 a year
- Microsoft Outlook
- Sales
- Word processing
- 403(b) matching
- Mileage reimbursement
Quick Apply

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Regulatory Affairs Specialist I - Spine

Arthrex -
Naples, FL

Apply Now

Job Details

3 days ago

Benefits

Paid parental leave
Health insurance
Dental insurance
Flexible spending account
Tuition reimbursement
Paid time off
Parental leave
Employee assistance program
401(k) matching
Life insurance
Food provided

Qualifications

Project team coordination
Interpreting technical drawings
Physiology knowledge
Regulatory legal research
Schedule management
Managing projects
Cross-functional collaboration
Medical terminology
Stakeholder relationship building
Cross-functional communication

Full Job Description

Requisition ID:

67300

Title:

Regulatory Affairs Specialist I - Spine

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. We are actively searching for a Regulatory Affairs Specialist I, Spine for our global headquarters in Naples, FL.

The RA Specialist I – Spine is responsible for managing specific aspects of the Arthrex Regulatory Affairs program with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in the most efficient, compliant manner. This position will play a critical role in regulatory approval efforts. In coordination with management of Regulatory Affairs, this role will develop regulatory strategy, execute the regulatory plan, and perform other activities that lead to and maintain regulatory approval/clearance/licensure for Arthrex’s medical devices.

Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

Provide project teams with on-going support to resolve any real or perceived regulatory issues.
Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
Coordinate, prepare, write, submit and/or review regulatory submissions for projects in accordance with established product launch or other applicable timelines.
Coordinate efforts with regional counterparts associated with the preparation of international regulatory documents or submissions.
Review regulatory documentation for completeness, clarity, consistency and conformance to regulation, guidelines and internal policies/procedures to ensure all data and information is truthful, accurate and verifiable against source documentation to confirm compliance and traceability.
Establish, develop and maintain positive relationships with regulatory agency personnel.
Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products.
Maintain current knowledge base of existing and emerging regulations, standards, and/or guidance documents.
Explain regulations, guidances, policies, and/or procedures to stakeholders, as applicable.
Recommend changes to company procedures in response to changes in regulations, guidances and/or standards.
Obtain and distribute updated information regarding domestic or international laws, guidances and/or standards.
Write or update standard operating procedures, work instructions, or policies.
Participate in internal or external audits, as required.

Education and Experience:

Bachelor’s degree required, engineering or science discipline preferred.
Advanced degree preferred.
Orthopedic medical device experience preferred.
Regulatory Affairs Certification (RAC) preferred.

Reasoning Ability:

Ability to identify and define problems, collect data, analyze established facts, draw valid conclusions, and effectively communicate the information both verbally and in writing to a variety of audiences. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to both appropriately format and develop a clear logic trail to establish conclusions based on an understanding of factual evidence. Ability to critically think; using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. Ability to actively learn; understanding the implications of new information for both current and future problem-solving and decision-making.

Abilities Requirements:

Ability to comprehend principles of engineering, physiology and medical device use. Ability to handle master documents, drawings, specifications, regulatory and clinical documentation with a high degree of confidentiality. Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents. Ability to review, collate, describe and summarize scientific and technical data. Ability to organize complex information and combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events) to produce answers that make sense. Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one. Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments. Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams. Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures. Ability to build strong relationships both internally and externally. Ability to work in a fast paced environment.

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of personal computers and computer programs, particularly SAP, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).

Language and Communication Skills:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.

Arthrex Benefits

Medical, Dental and Vision Insurance
Company-Provided Life Insurance
Voluntary Life Insurance
Flexible Spending Account (FSA)
Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
Matching 401(k) Retirement Plan
Annual Bonus
Wellness Incentive Program
Free Onsite Medical Clinics
Free Onsite Lunch
Tuition Reimbursement Program
Trip of a Lifetime
Paid Parental Leave
Paid Time Off
Volunteer PTO
Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.

Apply Now

Refine Your Search

technical specialist jobs in naples, fl

Regulatory Affairs Specialist I - Spine

Safety Professional I

Account Cancellation Specialist

Event Technical Specialist (Video) Part Time on call- Naples market

Staffing Specialist / Recruiter

Lab Technologist Specialist

Business Development & Sales Specialist

Safety Professional I

Technical Support Specialist

Accounts Payable Specialist I

Biocompatibility Specialist II

Seasonal, Operations Technical Specialist (Part Time)

Installation Project Specialist - Synergy

Travel Specialist II (2nd Shift - Hybrid 1 Day Onsite))

Assets Protection Specialist

Procurement Specialist

Clinical Sales Specialist, Electrophysiology - LAAO - Naples, FL

Lab Technologist Specialist

Irrigation Specialist

ANNUAL GIVING SPECIALIST

I want to receive the latest job alert for technical specialist in naples, fl

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