Top 44 Director of regulatory affairs Jobs in Plano Tx

Director, Regulatory Affairs
Argon Medical Devices Inc —Plano, TX
- Full-time
- Remote
- Bachelor of Science
- 8 years
- Analysis skills
Executive Director
Brookdale Senior Living Inc. —Rockwall, TX
- Nights as needed
- Writing skills
- 3 years
- Ability to lift 50 pounds
- Health savings account
- Paid holidays
Quick Apply
5d
Dialysis Facility Administrator
U.S. Renal Care —Dallas, TX
- Full-time
- Nursing
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Dental insurance
8d
Director of Compliance & Privacy
Prism Health North Texas —Dallas, TX
- Full-time
- HIPAA
- 3 years
- Bachelor's degree
Quick Apply
Director, Financial Aid
American Career College —Richardson, TX
- $86,434.51 - $125,335.55 a year
- Full-time
- 5 years
- University
- Bachelor's degree
Associate Director, Corporate Compliance
Oscar Health —Dallas, TX
- $134,136 - $176,053 a year
- Overtime
- Remote
- 5 years
- HIPAA
- Continuous improvement
- Paid parental leave
- Paid holidays
Quick Apply
5d
Director, Government Affairs
Heidelberg Materials —Irving, TX
- $172,170.00 - $229,563.32 a year
- Full-time
- Office
- Project management
- Bachelor's degree
- Health savings account
- AD&D insurance
Senior Regulatory Affairs Analyst
Keurig Dr Pepper —Frisco, TX
- $76,400 - $115,000 a year
- Email
- Microsoft Word
- Microsoft Access
- 5 years
- Mileage reimbursement
- Paid parental leave
Senior Director Corporate Affairs
Bimbo Bakeries USA —Irving, TX
- $105,100 - $147,100 a year
- 11+ years
- Bachelor's degree
- Senior level
- Paid time off
- 401(k) matching
1d
Regulatory Affairs Manager
Katalyst Healthcares & Life Sciences —Dallas, TX
- Contract
- Bachelor's degree
- Senior level
- Leadership
Quick Apply
Director - Medical Policy
Caris MPI, Inc. —Irving, TX
- $200,000 - $215,000 a year
- Full-time
- 7 years
- Pass drug screening
- Analysis skills
- Health savings account
- Disability insurance
Sr. Regulatory Affairs Manager
Katalyst Healthcares & Life Sciences —Dallas, TX
- Contract
- Management
- 5 years
- Analysis skills
Quick Apply
Director of Government Relations
Progress Residential —Farmers Branch, TX
- Full-time
- 7 years
- Pass drug screening
- Residential
- Paid holidays
- Health insurance
Quick Apply
Executive Director, Program Strategy (Physical Therapy Programs)
The University of St. Augustine for Health Sciences —Dallas, TX
- $126,000 - $180,600 a year
- Hybrid work
- Microsoft Excel
- 5 years
- Office
- Paid holidays
- Disability insurance
Director of Legislative Policy Strategy
Applied Digital Corporation —Dallas, TX
- Full-time
- Office
- Master's degree
- 8 years
Quick Apply
Medical Staff Coordinator
Texas Health Resources —Dallas, TX
- Email
- Research
- Mid-level
- High school diploma or GED
- Paid parental leave
- Loan repayment program
Associate Director, Health IT
TSP (A Syneos Health Company) —Dallas, TX
- $140,000 - $180,000 a year
- 5 years
- Analysis skills
- Bachelor's degree
- Health insurance
- Dental insurance
Compliance Auditor
Prism Health North Texas —Dallas, TX
- Full-time
- Nursing
- HIPAA
- Mid-level
Quick Apply
Director of Clinical Quality Management
Baylor Medical Center at Frisco (10812) —Frisco, TX
- From $110,000 a year
- Full-time
- Microsoft Word
- Nursing
- RN License
Quick Apply
Medical Liaison - Rare Bleeding Disorders - Southwest - TX, OK, NM, AZ
Novo Nordisk —Dallas, TX
- $170,000 - $245,000 a year
- Doctoral degree
- Mid-level
- Driver's License
- Disability insurance
- Health insurance

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director of regulatory affairs jobs near plano tx

Director, Regulatory Affairs

Argon Medical Devices Inc -
Plano, TX

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Job Details

Full-time

Qualifications

Optimizing workflow processes
FDA submissions
Compliance risk assessment
Performance improvement leadership
Strategic management
ISO standards
Bachelor of Science
Professional ethics
Bachelor's degree in biomedical engineering
Legislative impact assessment
Biomedical Engineering
GMP
Regulatory legal research
8 years
Team development
Collaboration with product development teams
Analysis skills
Bachelor's degree
Medical device manufacturing facility experience
Decision making
Master of Science
Quality improvement
Quality compliance management
Mentoring
Document review
Leading team collaboration initiatives
Regulatory/legal compliance standards in production
Regulatory submission editing and review
Biomedical regulatory compliance
Senior level

Full Job Description

Company Overview::

Argon Medical Devices is a global manufacturer of specialty medical products, headquartered in Plano, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. Argon’s brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. Our values describe what we believe in and how we operate. These values are our moral compass which guide our decisions and define the deeply held beliefs and principles of our organizational culture. Argon Medical is a family of individuals united by a mission and culture which continue to grow stronger every day.

Position Overview::

The Director, Regulatory Affairs is responsible for leading strategic initiatives to ensure regulatory compliance while driving business growth across multiple regions. This key leadership role involves developing and implementing regulatory strategies, mentoring teams and managing critical interactions with regulatory agencies across the globe.

What you will do::

Oversee and provide expert guidance on regulatory requirements and ensure successful product submission strategies across multiple jurisdictions.
Working closely with cross-functional teams, this role will shape regulatory strategy for product development, product changes, manufacturing and commercialization while ensuring global compliance is maintained.
Actively communicate and collaborate with internal and external partners and across functions including Marketing, Commercial Regional Leaders, Engineering, R&D, Site Quality, Operations to support new product development and global registration strategy.
Identify, implement and maintain process improvements for global registrations, with particular focus on USFDA, EUMDR, UK and China.
Review and interpret regulatory and compliance requirements and guidance document as they related to company products, processes and QMS.
Monitors external device enforcement trends and provides detailed recommendations and action plans to address QMS approvements.
Mentor and develop regulatory affairs and cross functional teams.
Completes impact assessment of new regulations and document applicability for both Argon-branded and CPS manufactured lines.
Maintains current knowledge of external legislation, standards, guidelines, industry practices, and FDA submission requirements that impact medical devices and combination products.
Maintains active memberships and participation within relevant external medical device and combination product industry groups and committees.

Skills for Success::

BS/MS in either (Biomedical) Engineering, Science, or a related field.
8-12 years’ progressive experience at a global manufacturer of medical devices or at a regulatory agency.
Comprehensive knowledge of global regulatory requirements including FDA and global health authorities (EUMDR, Japan PMDA, ANVISA, MFDS, Health Canada, etc.).
Demonstrated expertise in regulatory compliance and quality management systems includes review, assessment and conformance to global regulatory standards.
Expert knowledge of FDA regulations, MDSAP, ISO 13485, ISO 14971, IEC 62366, IEC 62304 etc.
Strong knowledge of Quality, Regulatory Compliance, and operations systems and processes, including GMP, GCP and QMSR requirements for medical devices
Strategic thinking and analytical skills with the ability to interpret and apply regulatory requirements and industry best practices.
Strong analytical, organizational, communication, and interpersonal skills are required.
Excellent leadership, management, collaboration, and effective decision-making skills
Excellent interpersonal skills, negotiation and influencing skills. Strong oral and written communications skills with ability to speak to broad, non-technical audiences that are both internal and external personnel.
Ability to work in fast paced environment and rapidly shifting priorities while maintaining high ethical standards and integrity.
10 - 20% travel required.

Apply Now

Refine Your Search

director of regulatory affairs jobs in plano tx

Director, Regulatory Affairs

Executive Director

Dialysis Facility Administrator

Director of Compliance & Privacy

Director, Financial Aid

Associate Director, Corporate Compliance

Director, Government Affairs

Senior Regulatory Affairs Analyst

Senior Director Corporate Affairs

Regulatory Affairs Manager

Director - Medical Policy

Sr. Regulatory Affairs Manager

Director of Government Relations

Executive Director, Program Strategy (Physical Therapy Programs)

Director of Legislative Policy Strategy

Medical Staff Coordinator

Associate Director, Health IT

Compliance Auditor

Director of Clinical Quality Management

Medical Liaison - Rare Bleeding Disorders - Southwest - TX, OK, NM, AZ

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