Top 1796 Regulatory associate, surgery Jobs in Plano, Tx

Clinical Affairs Specialist III
Integer Holdings Corporation —Plano, TX
- Full-time
- Nursing
- Oracle
- 3 years
- Disability insurance
- Health insurance
Quick Apply
Ambulatory Surgery Center Scheduler
Willowbend Surgery Center —Plano, TX
- From $24 an hour
- Full-time
- Background check
- Customer service
- Medical office experience
- Health insurance
- Dental insurance
Quick Apply
4d
RN Day Surgery
Baylor Scott & White Health —McKinney, TX
- Full-time
- Nursing
- Surgery
- RN License
- Relocation assistance
- Health insurance
Portfolio Management Compliance Associate
Fisher Investments —Plano, TX
- Hybrid work
- Mid-level
- Office
- Microsoft Office
- Paid holidays
- Health insurance
HOA Portfolio Community Manager
FirstService Residential —Addison, TX
- $70,000 - $75,000 a year
- Full-time
- Computer literacy
- Mid-level
- Residential
- Paid holidays
- Health insurance
Quick Apply
Regulatory Associate, Surgery
UT Southwestern —Dallas, TX
- Full-time
- Surgery
- Mid-level
- Bachelor's degree
- Paid parental leave
- Paid holidays
Senior Regulatory Associate - Surgery - Surgical Sciences
UT Southwestern —Dallas, TX
- Online Application
- Surgery
- Mid-level
- 3 years
Regulatory Associate
CEDENT —Dallas, TX
- Contract
- Microsoft Excel
- Mid-level
- Project management
Surgery Scheduler
MSO - Vascular Care of Texas —Plano, TX
- Full-time
- Surgery
- Mid-level
- Employee stock purchase plan
- Disability insurance
Quick Apply
Patient Relations Specialist - Dallas
Baylor Scott & White Health —Dallas, TX
- Bilingual
- Hospital
- HIPAA
- Health insurance
- Tuition reimbursement
4d
Food Safety & QA Specialist / Associate
velandsystems —Dallas, TX
- $135,000 - $200,000 a year
- Full-time
- Hybrid work
- Word processing
- Mid-level
- Microsoft Office
- Health insurance
- Flexible spending account
Quick Apply
7h
Surgery Scheduler
TJI Frisco —Frisco, TX
- Full-time
- Surgery
- Mid-level
- Employee stock purchase plan
- Disability insurance
Quick Apply
Surgery Scheduler - Fort Worth, TX
UT Southwestern —Dallas, TX
- Full-time
- Surgery
- Medical office experience
- HIPAA
- Paid parental leave
- Paid holidays
13d
Professional Education Relations Associate
Abbott Laboratories —Irving, TX
- $86,700 - $173,300 a year
- Full-time
- Mid-level
- 3 years
- Presentation skills
- Health insurance
- Tuition reimbursement
OR Specialty Tech- Fulltime
Methodist Health System —Richardson, TX
- Full-time
- Acute care
- High school diploma or GED
- Operating room
7d
SR. CLINICAL TRIAL ASSOCIATE
TruMinds Clinical —Frisco, TX
- $108,867 a year
- Full-time
- Mid-level
- Office
- Master's degree
Research Enrollment Anlst
Baylor Scott & White Health —Dallas, TX
- Microsoft Excel
- Quality control
- Data entry
- Health insurance
- Tuition reimbursement
3d
Surgical Support Tech
Baylor Scott & White Health —Plano, TX
- Surgery
- Computer literacy
- BLS Certification
- Health insurance
- Tuition reimbursement
2d
Compliance Assistant
F & I Sentinel Llc —Dallas, TX
- $19.23 - $24.00 an hour
- Full-time
- Remote
- Mid-level
- Office
- Analysis skills
7d
Clinical Specialist, Joint Replacement - Dallas, TX
Stryker —Dallas, TX
- $65,900 - $91,600 a year
- Full-time
- Surgery
- Inventory management
- Customer service
- Health savings account
- AD&D insurance

I want to receive the latest job alert for regulatory associate, surgery in plano, tx

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 associate, surgery jobs near plano, tx

Clinical Affairs Specialist III

Integer Holdings Corporation -
Plano, TX

Quick Apply

Job Details

Full-time

Benefits

Disability insurance
Health insurance
Dental insurance
Paid time off
Adoption assistance
Parental leave
Vision insurance
401(k) matching
Life insurance

Qualifications

Product development research management
Data integrity assurance
Medical writing
Nursing
Content creation for technical audiences
Oracle
Safety protocol adherence
Team leadership
Technical documentation
Clinical staff development programs
Critical literature reviews
3 years
Minitab
Clinical audit and monitoring
Data integrity and documentation
Collaboration with product development teams
ICH guidelines
Clinical staff training
Product development projects
Budget planning
Technology management
Clinical training
Pharmaceutical company experience
Health information data integrity
Data quality monitoring
Clinical program monitoring
Health Science
Clinical data report preparation
Organizational skills
Technology budget management

Full Job Description

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

Customer

We focus on our customers’ success

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

You will adhere to Integer Core Beliefs and Values all safety, environmental, security and quality
requirements including, but not limited to: Quality Management Systems ( Safety, Environmental and
Security Management Systems, U.S. Food and Drug Administration ( regulations, company policies
and operating procedures, and other regulatory requirements.
You will contribute to global clinical strategies to support clinical evidence requirements for product
submissions and post submission activities.
You will represent the Clinical Affairs function on product development teams.
You will work directly with representatives from cross functional areas in possibly multiple geographical locations
You will ensure clinical data integrity in support of the quality and regulatory functional group needs. This will include the use of software to appraise, analyse and evaluate clinical and state of the art data to generate appropriate clinical evidence to support Integer Technologies
You will generate interim and final reports.
You will support Integer initiatives with the development and upkeep of market specific clinical training.
You will support investigator conferences to review findings and advise on direction.
You will interface with, and assure training of investigators/physicians, centre staff and Integer Clinical
Affairs staff.
You will support adequate monitoring is conducted on all clinical trials.
You will provide a clinical perspective and approval on field complaint investigations
You will work with regulatory bodies for the purpose of facilitating regulatory approvals and queries.
You will s upport the development of Integer technology including objectives, strategy, scope, budget, and schedule from proof of concept research, development through post market commercial phases
You will perform other functions as required.

How you will be measured:

The specific measures listed below may be subject to change and are not intended to be an all inclusive list
Safety is our highest priority; you will be an active supporter of the Integer Environmental, Health
Safety programs and the specific behavior based safety programs
You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.
Ensure clinical data arguments provided in clinical evaluation documents are sufficient to support regulatory product approvals
Support revenue growth by leveraging clinical knowledge to support the growth team initiatives
The creation of market specific clinical training
Ensure documentation and data are maintained to reflect State of the Art
Ensure State of the Art clinical processes are maintained and continuously underpinned by current knowledge and insight gained
Support the Development and maintenance of the physician advisory board to and its functions as directed
Cost You will be expected to complete clinical inputs for product approval and product renewal within budget
On Time Delivery particularly those that are impacted by the results of projects that you are involved in, and deliver ed by specified milestones
Your expertise coupled with your accomplishments and collaboration with others to deliver
results will also be considered.

What sets you apart:

You have a degree from higher education (Science, Engineering, Health Science, Nursing or related field
You have 3 years of documented professional experience; or 5-7 years of documented professional experience if a degree is not a prerequisite for a given task.
You have experience in medical device industry or pharmaceutical industry including US and international medical device regulatory submissions/approvals.
You have experience with implantable devices and/or other high risk device types.
You are suitably qualified as per MEDDEV 2.7.1 (rev 4), section 6.4 with experience of research methods, information management, literature reviews and technical writing.
You have knowledge and experience of clinical evaluations.
You have knowledge and experience with various medical device regulations such as the Medical Device Regulation (2017/ 21 CFR Part 812, and standards guidance documents such as MEDDEV 2.7.1 (rev 4) MDCG 2020 5, MDCG 2020 6, ICH Guidelines and their application
You have experience working with the medical community including physicians.
You have knowledge of feasibility, pivotal and post market clinical trials.
You can work independently as well as collaboratively within the organization.
You have developed good written and oral communication skills. This includes the ability to assist in teaching and training less experienced or knowledgeable associates. Clear and professional communications to all levels of the organization are important in this role
You have experience working in ERP systems, (such as Oracle, Reliance, etc.), Minitab, Excel, etc.
You have leadership skills with demonstrated ability to drive positive results and deliver projects on time for deliverables and within budget.

Salary range $75,750 - $111,00

#IND1

Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success. Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.

U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.

Quick Apply

Refine Your Search

regulatory associate, surgery jobs in plano, tx

Clinical Affairs Specialist III

Ambulatory Surgery Center Scheduler

RN Day Surgery

Portfolio Management Compliance Associate

HOA Portfolio Community Manager

Regulatory Associate, Surgery

Senior Regulatory Associate - Surgery - Surgical Sciences

Regulatory Associate

Surgery Scheduler

Patient Relations Specialist - Dallas

Food Safety & QA Specialist / Associate

Surgery Scheduler

Surgery Scheduler - Fort Worth, TX

Professional Education Relations Associate

OR Specialty Tech- Fulltime

SR. CLINICAL TRIAL ASSOCIATE

Research Enrollment Anlst

Surgical Support Tech

Compliance Assistant

Clinical Specialist, Joint Replacement - Dallas, TX

I want to receive the latest job alert for regulatory associate, surgery in plano, tx

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected