Administrative Assistant – Medical Device Job at Daley and Associates (Newark)

Non-Pharma Global Regulatory Affairs Specialist

The Global Regulatory Non-Pharma Specialist manages regulatory documentation and...

Location

Italy , Bologna

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

At least 5 years’ experience in Regulatory Affairs preferably within the food supplements, medical devices, and cosmetics sectors
Exposure to regulatory operations or documentation in EU and/or RoW markets or similar experiences is preferred
Advance degree in Life Sciences, Pharmacy, Chemistry, or a related field
Relevant certifications in Regulatory Affairs are considered a plus
Good knowledge of EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong attention to detail, time management and organizational skills
Willingness to learn and ability to work effectively in a team-based environment
Strong communication and interpersonal skills
Proficiency in Microsoft Office Suite and familiarity with document management systems
Fluent in English, both written and spoken

Job Responsibility

Contributing in a cross-functional team to provide the necessary regulatory input for the development of new projects
Support regulatory strategies by providing impact assessments
Collaborate actively with the Research & Development team to integrate regulatory requirements during the design and development of assigned products
Prepare, organize and submit regulatory documentation for submission and maintenance of dossiers for the projects assigned
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Manage multiple tasks in a fast-paced environment while keeping on task and to the company’s quality standards
Contribute to the preparation of regulatory project updates in internal meeting and governance committee providing regulatory input and flagging risks
Assist colleagues with administrative tasks
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Review and validate commercial artwork, packaging, and labeling in compliance with EU Regulations, ensuring timely product launches

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

New

Emergency Care Technician

Under the supervision of an RN, performs basic patient care activities and conti...

Location

United States

Salary:

Not provided

Memorial Healthcare System

Expiration Date

Until further notice

Requirements

Vocation Technical
BLS American Heart E-Card (BLS AHA ECARD) - American Heart Association
BLS American Heart RQI E-Card (BLS AHA-RQI ECARD) - American Heart Association
BLS Cert American Heart_non ecard (BLS AHA) - American Heart Association
BLS Certification Grace (BLS GRACE) - Employee Grace Period for Essential Credential
BLS Cert Red Cross (BLS RC) - Red Cross
Paramedic License (PMD LICENSE) - State of Florida
Must be EKG and Phlebotomy certified
No experience required
Certified as a Nursing Assistant (CNA) with certifications for EKG and Phlebotomy program

Job Responsibility

Assists physicians and nurses with performing medical procedures, including examinations, minor surgical interventions, orthopedic treatment, and resuscitation
Upon successful completion of training and demonstration of clinical competency, will be able to perform the following functions in Emergency Departments when approved by and under the supervision of the Emergency Services Medical Director: Ultrasound Guided Peripheral IV Placement, Intraosseous (IO) placement, Insertion of Nasogastric Tube, Triage (all aspects except Acuity Level Designation), IV Fluid Administration, Medication Administration (limited), Operation of IV infusion device (IV pump)
Performs technical procedures as delegated, including but not limited to establishing IV access, performing ECGs and vital statistics/telemetry monitoring, collecting specimens, providing wound care, and transporting patients
Documents and communicates assessment findings or changes in physical, mental and emotional conditions to medical/nursing staff
Assists with keeping department areas clean, stocked, and orderly

Fulltime

Analyst Coder Supervisor

Location

United States , Landover, MD

Salary:

Not provided

PN Automation, Inc

Expiration Date

Until further notice

Requirements

Bachelors of Science in Nursing and/or 4 years of progressively more responsible managerial experience
Clinical experience in the different medical specialties
Team player, flexible, and sensitive to time related deadlines
An astute attention to detail and the ability to effectively communicate with direct reports, colleagues, senior management and the FDA client
Ability to adapt and implement changing regulations and procedures
Basic computer and typing skills

Job Responsibility

Supervise a team of Analyst Coders that reviews, edits, prioritizes, and analyzes adverse medical events related to medical devices that are submitted on MedWatch forms to the FDA
Analyze, prioritize and organize daily workloads for the team for the many different types of reports
Accountable for ensuring that the contract deliverables are met and/or exceeded on the daily basis
Edit reports to maintain the specified Federal privacy and anonymity guidelines
Analyze daily workloads to identify the product, manufacturer, device problems or malfunctions that contributed to the adverse event of the device
Perform editorial responsibilities to assist and guide the data entry staff in the entry of reports into the FDA database
Monitor performance outcomes and conduct periodic evaluations for direct reports
Coach, counsel and discipline direct reports as needed to achieve favorable performance outcomes
Perform strategic thinking to mitigate problems that could adversely impact the project
Participate in team and management meetings to discuss coding and personnel issues

Fulltime

Regional Sales Manager

Regional Sales Manager for Heraeus Covantics, a leading materials specialist in ...

Location

United States

Salary:

Not provided

Heraeus Holding GmbH

Expiration Date

Until further notice

Requirements

Bachelor’s degree in business, Biology or related field required
Master's degree preferred
A minimum of 4 years of experience in the medical industry and medical device sales required
Experience managing direct reports preferred
Must have a strong sales background with demonstrated performance record
ability to learn medical device product platform
Self-starter, independent sales management skills
Direct sales training and experience in medical device industry required
Applicants must currently reside in the state of Arizona

Job Responsibility

Grow the market share of HME products in the defined geographic area and achieve or exceed sales quota
Develop relationships with decision makers (clinical, technical, and economic) in geographic area
Cold call and visit prospects on location, set appointments with hospital staff and administrators, Manage all leads and customers within a defined territory
Keep CRM software updated with appropriate information, educate medical staff on the use and benefits of medical devices, Provide product demonstrations and support
Ensure smooth ordering at all accounts (new and existing), Maximize account penetration by selling all products in portfolio
Communicate between sales, marketing, and support teams to improve customer experience
Collect, analyze, and present field sales data to assist with strategy planning and implementation
Support and champion the regional sales strategy, Develop and execute territory business plan
Support, train and develop sales reps/ sales agents on products, services, and any corporate level initiatives
Oversee and manage multiple territories and associated sales reps/sales agents

What we offer

An innovation-driven work environment
Global teamwork
The opportunity to take an active role in social and environmental responsibility
Equal access to opportunities
Fair and equal consideration to all qualified applicants
A diverse and inclusive culture

Fulltime

Crmg medical assistant - family medicine

Medical Assistants demonstrate advanced critical thinking skills in the clinic s...

Location

United States , Cheyenne

Salary:

Not provided

Cheyenne Regional Medical Center

Expiration Date

Until further notice

Requirements

High school diploma (or equivalent certificate from an accredited program) or higher degree
14 Days: Cheyenne Regional AHA RQI within fourteen (14) calendar days of start date
60 Days: Current Medical Assistant (MA) certification/registration within 60 days of start date
Cheyenne Cardiology, Nephrology Clinic, Podiatry, and Vascular and CT Clinic Only: Valid USA driver’s license
Must have clean driving record that follows Cheyenne Regional Medical Center’s driving guidelines

Job Responsibility

Obtains, verifies, and updates patient information and health history. Charts patient information into the medical record as reported by the patient
Assists patients with ambulation, transfers, assistive device instruction, body mechanic instruction, and activities of daily living
Obtains patient vital signs, administers basic wound and first aid, and therapeutic modalities
Performs phlebotomy, point of care testing, and specimen handling
i.e. urine, throat, vaginal, stool, and sputum
Administers subcutaneous injection, intramuscular injection, intradermal injection, and medication administration (with the exception of narcotics)
Performs electrocardiography including placement of electrodes and obtaining EKG results
Assists in minor surgeries, including surgical tray set-up, pre/post-surgical care, and suture removal
Set-up instruments and equipment according to department protocols
aseptic/sterile technique and basic decontamination, instrument wrapping, cleaning of exam/procedure room/instruments/and equipment between patient visits to maintain infection control requirements

What we offer

403(b) with 4% employer match
ANCC Magnet Hospital
21 PTO days per year (increases with tenure)
Education Assistance Program
Employee Sponsored Wellness Program
Employee Assistance Program
Loan Forgiveness Eligible

Fulltime

New

Medical Education Administrative Officer

Medical Education Administrative Officer. We are seeking a Medical Education Adm...

Location

United Kingdom , Newcastle upon Tyne

Salary:

24937.00 - 26598.00 GBP / Year

Cumbria, Northumberland, Tyne and Wear NHS...

Expiration Date

Until further notice

Requirements

English and Maths GCSE A-C or equivalent level
Word-processing skills at Level 3 (OCR/RSA Level 3) or equivalent qualification(s) in relevant subjects or equivalent level of knowledge
Capable of working with confidential and sensitive information
Ability to work under pressure, and maintain a customer-service focus, often with constant interruptions by telephone, urgent emails or in person
Proven ability to use Microsoft Office and related packages, including databases, spreadsheets, and inputting and updating electronic information
Ability to work alone with minimal supervision and manage own time and workload effectively
Capable of working with confidential and sensitive information
Sound knowledge of Medical Education
Excellent customer service experience including handling queries, complaints, and sensitive information
Experience of team working to achieve deadlines and objectives

Job Responsibility

Assisting in the provision of high level administrative support and coordination for the delivery of postgraduate teaching north of Tyne
Working closely with Medical Education Administrator, Medical Education Lead, Medical Education Manager, Medical Education team, Simulation & Education Development Leads, Teaching Fellows and Resident Doctors to deliver postgraduate education
Assisting with the training delivery of postgraduate trainee development programme courses
Supporting planning and organisation of Resident Doctor's inductions
Assisting with the organisation of North Tyneside & Newcastle postgraduate weekly teaching
Compiling teaching attendance records, issuing certificates, and collecting feedback for postgraduate teaching events
Issuing requests for IT accounts for all grades of resident doctors
Requesting lone working devices, supporting queries and non-usage
Providing admin support for simulation events by assisting with set up, timing and role players
Assisting with arranging mid point review meetings between trainee doctors and college tutors

Fulltime

Biomedical Specialist

The BioMedical Specialist is a Subject Matter Expert (SME) and provides clinical...

Location

United States , Douglasville

Salary:

Not provided

Wellstar Health System

Expiration Date

Until further notice

Requirements

Associates Biomedical Engineering or other
CompTIA A+ Certification Upon Hire Preferred or Cert Biomed Engineering Tech Upon Hire Preferred
Minimum 5 years of experience in supporting medical devices and systems in a hospital environment
Minimum 5 years Knowledge of electronic digital circuitry and understanding of electronic and electro-mechanical device
Proficient in Microsoft Office software including Word, Excel, and PowerPoint
Capable of interpreting building architectural and systems drawings and information
Able to compose and deliver presentations regarding medical devices and systems to clinical staff
Working knowledge of Security Protocols

Job Responsibility

Perform calibrations and repairs on equipment as assigned
Demonstrate knowledge of safe and approved troubleshooting techniques on medical devices
Read schematics and service manuals, consult with vendors and service representatives to assist in troubleshooting
Utilizes test equipment and complete complex repairs in a time and cost-effective manner with patient safety as the primary focus
Document work performed and any significant performance data accurately and in a timely manner
Provide leadership during project planning and equipment implementations
Serve as an advisor to administrative, medical, and clinical staff in the safe use and proper operation of clinical equipment and aids in the selection process for new equipment
Operates as part of a team of engineers responsible for providing in depth technical knowledge required to implement, manage, upgrade and support many applications and interoperability into EPIC and other repositories
Responds to service calls to evaluate, diagnose, and perform corrective and preventive maintenance on complex biomedical equipment
Coordinates work performed by service contractors and vendors

Fulltime

New

Senior Principal Regulatory Affairs Specialist - Transfusion

As a Senior Principal Regulatory Affairs Specialist, you will perform regulatory...

Location

United States , Norcross

Salary:

Not provided

werfen

Expiration Date

Until further notice

Requirements

Bachelor’s degree (BS/BA) from four-year college or university
or equivalent combination of education and experience
RAC certification, preferred
Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, and government regulations
Ability to write reports, business correspondence and procedure manuals
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference and volume
Ability to apply concepts of basic algebra and geometry
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exist
Ability to interpret a variety of instructions furnished in written, oral, diagram, and schedule form

Job Responsibility

Coordinates preparation, review and submission of product applications (510(k), BLA, Medical Device Licence Applications/Amendments, and Technical Documentation
Prepares and maintains Technical Files (Technical Documentation)
Reviews and approves quality system documents to determine compliance with SOPs, quality system and regulatory compliance, and industry standards
Reviews and approves significant changes (e.g. facility, product, process and labeling changes) for regulatory impact and domestic and international reporting requirements
Maintain regulatory product files of information submitted in support of domestic and international registrations
Coordinates field action and vigilance activities for Werfen product lines and notifies appropriate regulatory agencies, affiliates and distributors
Performs tasks and functions associated with product recalls/field corrections including preparing customer notifications, government submissions, status reports and recall effectiveness checks
Evaluates complaint and internal deviation report data to determine the need for Medical Device Reporting, field action or Biological Product Deviation reporting
Maintains compliance with Medical Device Listing requirements for Werfen products
Recognizes and elevates critical regulatory/compliance issues to RA management

Fulltime

Administrative Assistant – Medical Device

Daley and Associates

Location:
United States , Newark

Category:
Office Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 08, 2026

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