Senior Healthcare Regulatory Specialist (SaMD) Job at Gipo (Barcelona)

Senior Healthcare Regulatory Specialist (saMD)

The Risk & Compliance team ensures Docplanner meets regulatory requirements whil...

Location

Spain , Barcelona

Salary:

Not provided

DocPlanner GmbH

Expiration Date

Until further notice

Requirements

Strong knowledge of EU Medical Device Regulation (MDR), particularly in a Software as a Medical Device (SaMD) context
Practical experience in medical device regulatory affairs and solid understanding of Quality Management Systems (QMS) and regulatory governance frameworks
Relevant academic background (law, medicine, pharmacy, engineering, or scientific field) or the equivalent hands-on experience in medical device regulatory/QMS experience
Experience with EUDAMED, CAPA systems, and post-market surveillance tools
Ability to manage cross-functional regulatory projects independently and work with multiple stakeholders
Strong communication skills with both internal teams and external regulatory authorities
Fluent in English
Spanish or other EU languages are a plus

Job Responsibility

EU MDR Compliance: Achieve mandatory Medical Device Regulation certification to maintain European market access
Support Global Certification Processes: Lead MDR certification and other accreditation (ISO, C5) processes across target jurisdictions to enable market expansion and continuance
Establish Compliant Governance Framework: Build robust governance systems that stakeholders and customers can trust, ensuring business integrity and regulatory adherence
Risk Mitigation & Business Protection: Prevent regulatory fines and reputational harm that could impact our ability to serve patients and healthcare providers
Process Optimization: Continuously assess and improve compliance processes to align with the dynamic needs of the increasingly regulated digital healthcare industry

What we offer

Healthcare insurance
Wellness that works for you – from gym memberships to mental health support
Time off that counts – whether it’s a vacation, your birthday, or just a day to recharge
ESOP (Employee Share Option Plan) after 6 months
Local Perks – Depending on your location, you will be entitled to local benefits like meal vouchers (ticket restaurant), transport allowances, or extended parental leave
Career Growth – lots of chances to learn, develop, and explore new paths
A Truly Global Team – Work with talented people from all over the world
Flexibility That Works for You – Remote work and flexible hours

Fulltime

New

Major Construction Project Manager

Opportunity: Major Construction Project Manager - Aliso Viejo, CA. SD Solutions,...

Location

United States , Aliso Viejo

Salary:

100000.00 - 125000.00 USD / Year

SD Solutions, LLC

Expiration Date

Until further notice

Requirements

Bachelor's degree is required with a minimum of 5 years of experience in performing large commercial or government construction related project management activities
Experience in the field may substitute for a degree
Possess a proven experience developing and maintaining working relationships with high level officials and technical experts
Experience with writing and developing projects
Experience writing and developing PRDs, SOWs, SOOs, PWSs, and IGCEs (experience drafting the commercial equivalents of these documents may be acceptable)
Proficiency and experience with RSMeans or similar construction cost estimating software
Ability to conduct analytic assessments of work plans and progress reports and identify strengths and weaknesses
Ability to work collaboratively with all team members
Excellent written and oral communication skills
Familiar with Microsoft office suite of programs, especially MS PowerPoint, Excel, and Word

Job Responsibility

Manages the budget, schedule, and requirements of multiple concurrent major construction, renovation, and other large repair projects
Liaises between project managers, other governmental entities, upper management, and international border partners
Supports project planning, production, quality, project financial, and staff direction and oversight, and providing deliverables under the task order
Reports on project progress and respond to inquiries about projects from client management and Congress
Interface regularly with stakeholders to Project Managers, and other U.S. Government agencies and components
Manages the budget, schedule, and requirements of multiple concurrent projects
Liaise between other government agency project managers and representatives, upper management and international partners to ensure that projects align with the goals of each stakeholder
Develops scopes of work and project requirement packages for new projects in the portfolio
this involves working with stakeholders to determine the requirements of the project and liaise with the technical experts who can develop project strategy/solutions (engineering, environmental, real estate, and cost estimates) for these requirements
Assists government stakeholders to create and manage the budgets and schedules and prioritizing of current and future year construction project plans for the program

What we offer

Relocation assistance
Sign-on bonus
Eligible for paid benefits
Candidate Referral Fee Program

Fulltime

New

Epicor Kinetic Consultant

We are looking for an Epicor Kinetic Consultant to provide hands-on ERP support ...

Location

United States , Alsip

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

At least 3 years of practical experience working with Epicor Kinetic in a hands-on support or administration capacity
Proven ability to administer, maintain, and troubleshoot Epicor environments with minimal ramp-up time
Experience creating or modifying dashboards, BAQs, and reports within Epicor
Solid understanding of ERP workflows, business processes, and issue resolution in a manufacturing setting
Background providing direct end-user support along with clear, effective communication and documentation
Manufacturing industry experience is preferred
Familiarity with BPMs, system customizations, and reporting tools is an advantage

Job Responsibility

Provide day-to-day administration and support for the Epicor Kinetic environment to maintain reliable system operations
Investigate application, configuration, and workflow issues, then implement effective resolutions in a timely manner
Build, revise, and optimize dashboards, BAQs, and reporting tools to support business visibility and decision-making
Partner with internal users to address process questions, resolve system challenges, and improve overall ERP utilization
Deliver direct user guidance and informal training to help teams work more effectively within Epicor Kinetic
Document system changes, support activities, and recommended practices to improve continuity during the contract period
Assist with BPMs, customizations, and reporting-related enhancements when needed to support operational requirements

What we offer

medical
vision
dental
life and disability insurance
eligibility to enroll in 401(k) plan

New

Grad Pharmacist

You've invested a lot of time and energy in your education. Now you want the cha...

Location

United States , Pearland

Salary:

23.75 - 42.00 USD / Hour

CVS Health

Expiration Date

September 30, 2026

Requirements

PharmD graduate of a U.S. accredited program prior to beginning the Post-Graduate Training Program at CVS Health
Ability to obtain required pharmacist licensure within the required timeframe, per state guidelines. Failure to obtain required Pharmacist licensure within 120 days of graduation will result in separation of employment.
Must possess, or be in the process of obtaining, valid intern and/or technician licensure as required
Regular and predictable attendance, including nights and weekends
Ability to complete required training within designated timeframe
Attention and Focus: Ability to concentrate on a task over a period of time
Ability to pivot quickly from one task to another to meet patient and business needs
Ability to confirm prescription information and label accuracy, ensuring patient safety
Customer Service and Team Orientation: Actively look for ways to help people, and do so in a friendly manner
Notice and understand patients' reactions, and respond appropriately

Job Responsibility

Living our purpose by following all company SOPs at each workstation to help our Pharmacists and Technicians manage and improve patient health
Following pharmacy workflow procedures at each pharmacy workstation (i.e., production, pick-up, drive-thru, and drop-off) for safe and accurate prescription fulfillment
Contributing to positive patient experiences by showing empathy and genuine care: creating heartfelt and personalized moments while serving patients at pick-up, drive-thru, and over the phone
keeping patients healthy by offering immunizations and other services at the register and over the phone
and demonstrating compassionate care by solving or escalating patient problems
Offering to counsel, fielding medical questions, and soliciting information on a patient's medical history to provide optimal care, when appropriate under the direct supervision of a licensed pharmacist
Taking telephonic prescriptions from the prescriber, and calling the prescriber to clarify prescriptions or facilitate medication changes, where allowed by state regulation
Maintaining the highest level of self-awareness and providing in-the-moment coaching, training, and mentoring to pharmacy team members while sharing best practices
Completing basic inventory activities, as permitted by law, and as directed by the pharmacy leadership team, such as accurately putting away medication deliveries and completing cycle counts, returns-to-stocks, waiting bin inventories, etc.
Contributing to a high-performing team, embracing a growth mindset, and being receptive to feedback

What we offer

dental
vision
wellness resources
employee discounts
access to certain voluntary benefits
other programs

Parttime

New

Operations Superintendent - Rolling

Proven to Perform. From the edges of space to the bottoms of ocean, our material...

Location

United States , Richburg

Salary:

Not provided

ATI

Expiration Date

Until further notice

Requirements

4-year College Degree or equivalent work experience
Minimum 3 years' leadership experience in a high-tech manufacturing environment
Minimum of 2 years' experience with Lean Principles in a manufacturing environment
Experience managing, guiding, and developing employees
Proficient in Microsoft Office tools (Word, Excel, and Power Point at a minimum) required to accomplish day-to-day work activities and willingness to learn additional programs
Sufficient knowledge of company, products, objectives and operations
Advanced knowledge of production, operations, and materials planning, practices, and processes
Exceptional analytical, critical thinking and problem-solving capabilities
Effective interpersonal, leadership, and written and verbal communication skills
Excellent attention to detail, organization, and time management and prioritization skills

Job Responsibility

Direct safety program ensuring employee's safety and participation to established goals
Research, propose and implement improvements using Lean Manufacturing principles to meet performance goals as well as improve safety, quality, efficiency, costs, and scrap
Manage personnel including task assignment, performance management, policy adherence and development
Work closely with Maintenance, Planning, Purchasing, Technology, Quality and Human Resources and other support functions to meet business plan requirements

Fulltime

New

Production Worker

Proven to Perform. From the edges of space to the bottoms of ocean, our material...

Location

United States , Vandergrift

Salary:

Not provided

ATI

Expiration Date

Until further notice

Requirements

1 year of experience in a transferrable industry with transferrable skills
Basic reading, math, and measurement comprehension

Job Responsibility

Operating equipment and performing tasks such as operating labor, general labor and light mobile equipment operation as required to support and maintain plant operations
Supports and assists in maintenance activities
Operate both small and large mobile equipment
Operate cranes using a remote radio control box or in an overhead cab
Work with a team in the various facilities to produce world class plate products
Assist and support routine maintenance activities

Fulltime

New

Erp Reporting Specialist

Robert Half is seeking an experienced Oracle Fusion Report Consultant to support...

Location

United States , Salem

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Proven experience in Oracle Fusion Reporting
Knowledge in Oracle Fusion Cloud reporting using OTBI or BI Publisher
Experience across ERP modules like Cash Mgmt, GL, PPM, and HCM
Ability to train and mentor end users around Oracle Fusion Reporting
Strong communication skills for client-facing members

Job Responsibility

Design, develop, and deploy reports using Oracle Fusion reporting tools, including OTBI, BI Publisher, and Oracle BI Analytics
Work through a prioritized backlog of ERP and HCM reports in support of implementation milestones
Build standard operational and financial reports across General Ledger, Cash Management, Project Portfolio Management (PPM), hiring, terminations, payroll, and other Oracle Fusion modules
Collaborate with Finance, HR, and project stakeholders to gather reporting requirements and validate report outputs
Provide hands-on reporting support throughout implementation and go-live activities
Train and mentor internal team members on Oracle Fusion reporting tools, report maintenance, and best practices
Troubleshoot reporting issues and recommend improvements to reporting processes

What we offer

medical
vision
dental
life and disability insurance
401(k) plan

Fulltime

New

Major Construction Project Manager

Opportunity: Major Construction Project Manager - Indianapolis, IN Corporate Ov...

Location

United States , Indianapolis

Salary:

Not provided

SD Solutions, LLC

Expiration Date

Until further notice

Requirements

Bachelor's degree is required with a minimum of 5 years of experience in performing large commercial or government construction related project management activities
Experience in the field may substitute for a degree
Possess a proven experience developing and maintaining working relationships with high level officials and technical experts
Experience with writing and developing projects
Experience writing and developing PRDs, SOWs, SOOs, PWSs, and IGCEs (experience drafting the commercial equivalents of these documents may be acceptable)
Proficiency and experience with RSMeans or similar construction cost estimating software
Ability to conduct analytic assessments of work plans and progress reports and identify strengths and weaknesses
Ability to work collaboratively with all team members
Excellent written and oral communication skills
Familiar with Microsoft office suite of programs, especially MS PowerPoint, Excel, and Word

Job Responsibility

Manages the budget, schedule, and requirements of multiple concurrent major construction, renovation, and other large repair projects
Liaises between project managers, other governmental entities, upper management, and international border partners
Supports project planning, production, quality, project financial, and staff direction and oversight, and providing deliverables under the task order
Reports on project progress and respond to inquiries about projects from client management and Congress
Interface regularly with stakeholders to Project Managers, and other U.S. Government agencies and components
Manages the budget, schedule, and requirements of multiple concurrent projects
Liaise between other government agency project managers and representatives, upper management and international partners to ensure that projects align with the goals of each stakeholder
Develops scopes of work and project requirement packages for new projects in the portfolio
this involves working with stakeholders to determine the requirements of the project and liaise with the technical experts who can develop project strategy/solutions (engineering, environmental, real estate, and cost estimates) for these requirements
Assists government stakeholders to create and manage the budgets and schedules and prioritizing of current and future year construction project plans for the program

What we offer

Relocation assistance and sign-on bonus available for qualified candidates who receive their clearance and subsequently become employed with SD Solutions for this position
We will also provide you with a referral bonus if you are able to successfully refer a candidate who is employed with us in this position for 90 consecutive days or more
Eligible for paid benefits
Extremely competitive compensation and an extremely attractive benefits package

Fulltime

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Senior Healthcare Regulatory Specialist (SaMD)

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