20 Best Director Of Regulatory Affairs jobs (Hiring Now!)

Director, Medical Safety Officer
Edwards Lifesciences —Irvine, CA
Provide input on clinical trial design and develop safety sections of study protocols, regulatory submissions, and clinical/regulatory reports.
$166,000 - $235,000 a year
Regulatory Affairs Coordinator
ERG RICHMOND BEHAVIORIAL ASSOCIATES LLC —Staten Island, NY
The Regulatory Affairs Coordinator is responsible for a variety of clinical research operations duties of a routine and technical nature in support of clinical…
$26 - $32 an hour
Quick Apply
Respiratory Therapy Director
Riverside Health System —Newport News, VA
Evaluates and implements capital acquisitions and renovation/building projects for assigned area as approved including development of system purchases, cost…
Estimated: $110K - $140K a year
Quick Apply
12d
Licensed Nursing Home Administrator (LNHA)
Edenbrook Rochester —Rochester, MN
*Compliance and Regulatory Affairs:* Ensure compliance with state and federal regulations, licensing requirements, and accreditation standards.
Estimated: $99.9K - $126K a year
Quick Apply
4d
Associate Director/Director of Regulatory Affairs
U.S Tire Manufacturers Association —Washington, DC
Experience with federal and state regulatory processes and a variety of federal and state environmental laws and regulations, including the Clean Air Act and…
$140,000 - $190,000 a year
Quick Apply
5h
Assistant Director of Nursing
Citizens-Options Unlimited —Plainview, NY
Provide direct supervision to Residential Nurses, RNs and LPNs by maintaining ongoing supervisory interaction and conducting yearly evaluations; Ensure the…
$85,000 - $90,000 a year
Quick Apply
4d
Substance Abuse Therapist-Masters Level
Confidential —Palm Bay, FL
This staff includes advanced practice registered nurses, licensed practical nurses, masters level counseling staff, certified addiction professionals, physician…
$47,000 - $49,000 a year
Quick Apply
6d
Director, Public Policy
Alzheimer's Association —West Des Moines, IA
Must possess a valid driver’s license, good driving record, access to a reliable vehicle and proof of automobile insurance. Full time or Part time: *Full Time.
$60,000 - $70,000 a year
Quick Apply
Chief Financial Officer/Finance Director
Town of Dumfries, Virginia —Dumfries, VA
Monitor and review relevant federal and state laws and regulatory changes; develop, recommend, and implement needed changes to current accounting and auditing…
$100,000 - $165,000 a year
Quick Apply
12d
Governmental Affairs Director
Oregon Refuse & Recycling Association —Salem, OR
A valid driver’s license and proof of insurance. Building and maintaining relationships with members state-wide supported by frequent communications,…
$69,930.46 - $84,217.34 a year
Quick Apply
12d
Associate Director/ Director of Regulatory Affairs - Global Regulatory Lead
Ionis Pharmaceuticals, Inc. —Carlsbad, CA
The Associate Director / Director of Regulatory Affairs will help develop regulatory strategy and be an active partner in drug development project planning and…
$146,300 - $236,156 a year
Quick Apply
4h
Senior/Executive Director Regulatory Affairs
EPM Scientific —San Francisco, CA
Ability to develop and implement regulatory strategies in the Oncology field. Lead regulatory strategy, provide regulatory guidance/precedents; identify, assess…
$250,000 - $310,000 a year
Quick Apply
12d
Director of Regulatory Affairs (Remote)
ETR —Sacramento, CA
The use of a personal vehicle or rental car for ETR business will require a valid driver’s license; and proof of insurance. Able and willing to travel.
$126,700 - $154,900 a year
Quick Apply
5d
PLANT ENGINEER AND DIRECTOR OF MAINTENANCE AND PROJECTS
Harvey Mudd College —Claremont, CA
Interpret technical schematics, architectural blueprints, and specifications engaging in technical discussions with engineers and architects regarding campus…
$120,000 - $140,000 a year
Quick Apply
5d
Facility Administrator *Dialysis Experience - RN License"
Novo Dialysis, Flatlands —Brooklyn, NY
Do you have a valid RN license in NYS? Must meet any practice requirement(s) for the relevant state. Coordinate the functions of all departments and develop…
$110,000 - $140,000 a year
Quick Apply
Director of Business Excellence
Canopy Life Sciences LLC —Remote
Bachelor's degree in Life Sciences, Healthcare, Business Administration, or a related field. Identify, design, and implement process improvements to streamline…
$150,000 - $170,000 a year
Quick Apply
7d
Senior Director of Compliance
Didi Hirsch Mental Health Services —Culver City, CA
Leads all accreditation/certification agency-wide related activities which include but are not limited to initiating accreditation/certification, leading the…
$144,440 - $160,490 a year
Quick Apply
Executive Director
The Fedcap Group —Springfield, VA
A bachelor’s degree in business administration, Operations Management, or a related field with 10 yrs experience at the executive level is acceptable.
Estimated: $107K - $136K a year
Quick Apply
Campus Director & Dean of Academic Affairs & Operations
South University —Round Rock, TX
Key metrics include new student enrollment, student persistence (retention), B2B partnerships, affiliation agreements, budget plans, new programs, graduate…
$120,000 - $130,000 a year
Quick Apply
Sr. Director of Regulatory Affairs
Solar Energy Industries Association —Washington, DC
We will develop strategies, programs, and tools that seek to equalize opportunities within SEIA and allow for discussing and sharing best practices within the…
$170,000 - $180,000 a year
Quick Apply
7d

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Director, Medical Safety Officer

Edwards Lifesciences - Irvine, CA

Apply Now

Job Details

Full-time $166,000 - $235,000 a year

Qualifications

Nursing
Anatomy knowledge
Doctoral degree
Cardiovascular surgery
Master of Medical Science
Physiology knowledge
APRN
Pathology
Master's degree
8 years
Doctor of Philosophy
Master of Science
Cardiology
Master of Physician Assistant Studies
Relationship management
Clinical trials
MSN
Leadership
Communication skills
Negotiation
Interventional cardiology

Full Job Description

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

This role can be either an onsite or hybrid role based at Edwards’ Irvine campus, or a remote-based role in the U.S.

How you will make an impact:
The Director of Medical Safety Officer - Advanced Technology (AT) will develop a new safety division in the Advanced Technology business unit. An expert to provide technical expertise on safety assessments of adverse events and assure all events are reviewed and reported correctly. Identify patient and device safety issues for medical devices.

Analyze and conduct Sponsor assessment of adverse events and device deficiencies with the highest complexity reported through clinical studies (e.g. assessment of seriousness, relationship to device and procedure, and UADE (Unanticipated Adverse Device Effect) determinations). Determine what additional information is required for comprehensive assessment and adjudication, when required. Interact with site coordinators and trial managers for the purposes of safety data collection and data reconciliation.

Design CEC and DSMB/DMC charters, provide training to CEC and DSMB/DMC staff and physicians, and provide oversight of the overall process, including quality assurance of adjudication results and output.

Report complex adverse events and complaints according to regulatory requirements, trial safety processes and Edwards’ procedures. Respond to complex questions from regulatory authorities.

Review and analyze aggregate safety reports to identify early safety signals on complex safety issues and escalate to leadership with recommended next steps.

Represent safety in internal and external audits. Represent safety in cross-functional and core team meetings.

Develop and lead the implementation of safety processes according to applicable regulatory requirements.

Create or review and approve complex event narratives for internal review (e.g. R&D, quality, RA) or external review (Clinical Endpoints Committee), as well as for regulatory submissions.

Develop training materials and train Edwards and site personnel and safety committees on safety reporting and appropriate support documentation.

Create and provide oversight to complex clinical risk/benefit analysis documents to meet internal and regulatory requirements.

Provide input on clinical trial design and develop safety sections of study protocols, regulatory submissions, and clinical/regulatory reports.

Travel up to 25%

 What you will need (Required):
M.D, DO, Ph.D. or equivalent, 8 years’ experience of relevant medical/clinical and relevant industry experience.

Physician Assistant (PA) with a Master's degree in Physician Assistant Studies (MPAS), Health Science (MHS), or Medical Science (MMSc) or Nurse Practitioner (NP) with a Master's of Science in Nursing (MSN) or advanced practice registered nurse (APRN) or equivalent, 11 years’ experience of combined medical/clinical and relevant industry experience.

What else we look for (Preferred):
Experience in interventional cardiology/cardiovascular/cardiac surgery

Safety Experience (US and European)

Experience with Class III Medical Device

Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with KOLs and clinical personnel.

Ability to translate complex and technical information to project team management and key leadership.

Recognized as an expert in own area within the organization while applying advanced technical principles, theories, and concepts in related disciplines.

Expert knowledge of cardiovascular anatomy, pathology, and physiology

Expert understanding of medical device regulatory requirements, related documents, and reports.

Extensive knowledge of global adverse events reporting

In-depth understanding of corporate/global procedures, standard operating procedures, and writing practices.

Medical liaison with external physicians and clinicians

Provides expert medical input to help provide solutions to difficult technical issues and help drive organizational projects.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California the base pay range for this position is $166,000 to $235,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will accepted while this position is posted on our Career website.

Apply Now

Director Of Regulatory Affairs jobs

Director, Medical Safety Officer

Regulatory Affairs Coordinator

Respiratory Therapy Director

Licensed Nursing Home Administrator (LNHA)

Associate Director/Director of Regulatory Affairs

Assistant Director of Nursing

Substance Abuse Therapist-Masters Level

Director, Public Policy

Chief Financial Officer/Finance Director

Governmental Affairs Director

Associate Director/ Director of Regulatory Affairs - Global Regulatory Lead

Senior/Executive Director Regulatory Affairs

Director of Regulatory Affairs (Remote)

PLANT ENGINEER AND DIRECTOR OF MAINTENANCE AND PROJECTS

Facility Administrator *Dialysis Experience - RN License"

Director of Business Excellence

Senior Director of Compliance

Executive Director

Campus Director & Dean of Academic Affairs & Operations

Sr. Director of Regulatory Affairs

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