Top 102 Regulatory specialist Jobs in Cape Coral Fl

Regulatory Affairs Specialist I - Spine
Arthrex —Naples, FL
- Microsoft Excel
- Research
- Mid-level
- Paid parental leave
- Health insurance
4d
Journeyman Meter Specialist
Lee County Electric Cooperative (LCEC) —North Fort Myers, FL
- Up to $52.79 an hour
- 12 hour shift
- Background check
- OSHA
- Computer literacy
- Wellness program
- Health savings account
Communications Specialist II - Product
Arthrex —Naples, FL
- Marketing
- Computer literacy
- Research
- Paid parental leave
- Health insurance
4d
Nurse Practitioner (NP) – Retina Practice
Advanced Retina Institute —Bonita Springs, FL
- Full-time
- Nursing
- Patient monitoring
- BLS Certification
- Health insurance
- Dental insurance
Quick Apply
Clinical Reimbursement Specialist (MDS Coordinator)
Rehab & Healthcare Center of Cape Coral —Cape Coral, FL
- Full-time
- CPR Certification
- Microsoft Outlook
- RN License
- Health insurance
- Dental insurance
Quick Apply
RN - Cath Lab
Health Advocates Network, Inc. —Naples, FL
- $41.20 - $55.20 an hour
- Full-time
- Background check
- RN License
- BLS Certification
- AD&D insurance
- Disability insurance
Quick Apply
RSVP - W2 Life Insurance Specialist - Remote - Hiring Event
Insurance Supermarket Inc. —Florida
- $38,500 - $180,000 a year
- Full-time
- Computer literacy
- Mid-level
- Communication skills
- Health insurance
- Paid time off
Clinic Laboratory Operations Manager
Florida Cancer Specialists & Research Institute —Fort Myers, FL
- Full-time
- Background check
- Office
- Master's degree
- Tuition reimbursement
- 401(k) matching
11d
Clinical Laboratory Technologist
Florida Cancer Specialists & Research Institute —Fort Myers, FL
- Overtime
- Background check
- Vital signs
- BLS Certification
- Tuition reimbursement
- 401(k) matching
Inpatient Coder
Houston Methodist —Florida
- Full-time
- Anatomy knowledge
- English
- Mid-level
7d
Contract Specialist
LEESAR INC —Fort Myers, FL
- Hybrid work
- Microsoft Outlook
- English
- Mid-level
- Health savings account
- Paid holidays
Biocompatibility Specialist II
Arthrex —Naples, FL
- Microsoft Excel
- Bachelor of Science
- Mid-level
- Paid parental leave
- Health insurance
ENVIRONMENTAL SPECIALIST II - 64000519
The State of Florida —Fort Myers, FL
- $42,561.57 - $45,000.00 a year
- Full-time
- Background check
- Heavy lifting
- Ability to walk for extended periods
- Paid holidays
- Dental insurance
Performance Improvement Specialist
VITAS Healthcare —Cape Coral, FL
- Full-time
- Microsoft Word
- Microsoft Outlook
- OSHA
Quick Apply
ENVIRONMENTAL SPECIALIST I - 37020118
The State of Florida —Fort Myers, FL
- $45,290.16 a year
- 8 hour shift
- Background check
- Computer literacy
- Data analysis skills
- Paid holidays
- Dental insurance
5d
Program Manager
SENIOR FRIENDSHIP CENTERS INC —Fort Myers, FL
- Full-time
- Background check
- Hospitality
- Spanish
- 403(b) matching
- Paid holidays
Quick Apply
11d
ENVIRONMENTAL SPECIALIST II - 37001903
The State of Florida —Fort Myers, FL
- $4,203.34 - $50,440.08 a year
- Full-time
- Background check
- Mid-level
- Office
- Paid holidays
- Dental insurance
4d
CJIS Hardware, Software and Data Support Specialist
THE 20TH JUDICIAL CIRCUIT OF FLORIDA —Fort Myers, FL
- $66,722.76 a year
- Weekends as needed
- Hybrid work
- Azure
- Computer Science
- Mid-level
- Paid holidays
- Tuition reimbursement
12d
Chemistry Production Specialist
Watts Regulator Company —Fort Myers, FL
- Full-time
- Spanish
- Mid-level
- Residential
- Paid parental leave
- Paid holidays
Quick Apply
2d
Senior Operations Data Analyst - CDI
Lee Health —Cape Coral, FL
- $25.06 - $32.58 an hour
- Full-time
- Remote
- Microsoft Access
- Computer Science
- Research

I want to receive the latest job alert for regulatory specialist in cape coral fl

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

regulatory specialist jobs near cape coral fl

Nurse Practitioner jobs in Bonita Springs, FL

Data Specialist jobs in Fort Myers, FL

Environmental Specialist jobs in Fort Myers, FL

Coding Specialist jobs in Florida

Program Manager jobs in Fort Myers, FL

Insurance Specialist jobs in Florida

Clinical Laboratory Manager jobs in Fort Myers, FL

Contract Specialist jobs in Fort Myers, FL

Nurse Practitioner jobs in Farmington Hills, MI

Utilization Management Nurse jobs in Illinois

Nurse Practitioner jobs in Baltimore, MD

Nurse Practitioner jobs in Johnstown, PA

Nurse Practitioner jobs in Duluth, MN

Nurse Practitioner jobs in Savannah, GA

Adult Day Care Nurse Job jobs in New Jersey

Nurse Practitioner Substance Abuse Treatment jobs in Florida

Peer Support Specialist jobs in Winston Salem, NC

Data Analytics jobs in Binghamton, NY

Ese Specialist jobs in Florida

Data Specialist jobs in Gaithersburg, MD

Regulatory Affairs Specialist I - Spine

Arthrex -
Naples, FL

Apply Now

Job Details

4 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

regulatory specialist jobs in cape coral fl

Regulatory Affairs Specialist I - Spine

Journeyman Meter Specialist

Communications Specialist II - Product

Nurse Practitioner (NP) – Retina Practice

Clinical Reimbursement Specialist (MDS Coordinator)

RN - Cath Lab

RSVP - W2 Life Insurance Specialist - Remote - Hiring Event

Clinic Laboratory Operations Manager

Clinical Laboratory Technologist

Inpatient Coder

Contract Specialist

Biocompatibility Specialist II

ENVIRONMENTAL SPECIALIST II - 64000519

Performance Improvement Specialist

ENVIRONMENTAL SPECIALIST I - 37020118

Program Manager

ENVIRONMENTAL SPECIALIST II - 37001903

CJIS Hardware, Software and Data Support Specialist

Chemistry Production Specialist

Senior Operations Data Analyst - CDI

I want to receive the latest job alert for regulatory specialist in cape coral fl

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected