Senior Healthcare Regulatory Specialist (SaMD) Job at DocPlanner GmbH (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

Senior Healthcare Regulatory Specialist (SaMD)

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

Location

Spain , Barcelona

Salary:

Not provided

Gipo

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

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 – vacation, birthday, or just a day to recharge
ESOP (Employee Share Option Plan) after 6 months
Local Perks – meal vouchers (ticket restaurant), transport allowances, or extended parental leave
Career Growth – chances to learn, develop, and explore new paths
A Truly Global Team – Work with talented people from all over the world in a diverse and inclusive environment
Flexibility That Works for You – Remote work and flexible hours

Fulltime

Progression And Destination Tutor

We are seeking a Progress and Destination Tutor to join our team. In this role y...

Location

United Kingdom , Colchester

Salary:

28686.84 - 31284.24 GBP / Year

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Experience of working face to face with different age and client groups, but particularly with 16-19 year olds
Experience of supporting, motivating and mentoring individuals against goals
Experience of handling difficult situations, including confrontation, in a calm and effective way
Proven experience of working in a busy environment, managing conflicting priorities and meeting deadlines
Proven record of willingness to take initiative, adapt and being proactive
Proven record of working positively and collaboratively across internal teams, management, key stakeholders and colleagues developing and maintaining positive working relationships
Experience of working with various forms of communication including email, texting and telephone
Direct experience of inputting data into databases, accurately and with good use of English
Education to level 3 or above and/or a professional qualification in relevant subject area or equivalent
Minimum of Level 2 qualification in English and Mathematics GCSE 4+ or C and above / CSE Level 1 / O-Level C or above / Level 2 Adult Numeracy or Literacy or equivalent

Job Responsibility

Supporting students with their induction and orientation to the College
To have a particular focus in the first few weeks of the academic year on students who enrol late, or who show signs of disengagement or detachment
Reviewing students’ overall attendance, punctuality, behaviour, and attitudes to learning
To support the course team and students with to find, secure, record and complete, 30 hours of work-related experience placement
Delivery, developing and adapting Personal Development sessions and resources
Using relevant software such as Google classroom to deliver aspects of the Personal Development Programme
Developing a personal understanding of each tutee by holding regular one to one tutorials

Senior CRA

Location

Poland , Warsaw

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or healthcare-related field
Minimum of 2 years of experience as a Clinical Research Associate
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines
Strong organizational and communication skills, with attention to detail
Ability to work independently and collaboratively in a fast-paced environment
Willingness to travel as required (approximately 60%)

Job Responsibility

Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process
Collaborating with investigators and site staff to facilitate smooth study conduct
Performing data review and resolution of queries to maintain high-quality clinical data
Contributing to the preparation and review of study documentation, including protocols and clinical study reports

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Medical Records Clerk

We are looking for a detail-oriented Medical Records Clerk to support healthcare...

Location

United States , Falmouth

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Experience handling medical records in a healthcare, clinic, or related administrative environment
Working knowledge of electronic medical record systems and patient documentation practices
Familiarity with platforms such as Allscripts, Cerner, or similar medical record technologies
Strong attention to detail with the ability to maintain accuracy when entering and reviewing information
Understanding of confidentiality standards and proper handling of sensitive patient data
Ability to manage multiple priorities, stay organized, and meet deadlines in a fast-paced setting
Effective communication skills and the ability to collaborate with clinical and administrative staff.

Job Responsibility

Maintain and update patient files in electronic medical record systems to ensure information remains accurate, complete, and properly documented
Review submitted data for accuracy, correct discrepancies, and verify that patient details are entered in accordance with healthcare documentation standards
Retrieve and provide medical records to authorized personnel in a timely manner while safeguarding confidentiality at all times
Process record requests and documentation inquiries in alignment with established compliance and privacy guidelines
Scan, index, and file incoming documents so records are organized and easy for staff to access when needed
Work closely with medical and administrative teams to identify missing information and help keep patient charts current
Respond to routine questions related to records management and support day-to-day administrative tasks within the department.

What we offer

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

Fulltime

Regional Manager

You will inspire, coach, and create a collaborative working team within your reg...

Location

United Kingdom , Bournemouth / Exeter / Bristol / Southampton Area

Salary:

Not provided

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Significant experience of motivating, developing, and managing performance of direct reports (30 plus) to inspire operational excellence across multi-sites ideally in a convenience environment
Has the ability to interact and understand others, developing new relationships and builds on existing relationships to ensure trust and mutual respect
Successfully delivers long-term strategic plans and improvement of success measures whilst managing budgets
Uses a variety of leadership skills to get the best from an individual or situation which includes coaching to stretch the performance of others
Outstanding communication, presentation, and people skills
Ideally would have knowledge of food retail/off-licence and have been a remote manager
Has experience of leading change on multiple activities that have delivered sustainable change
Knowledge and Awareness of EHO and licensing guidelines, legal rules, and guidelines
Understands employment legislation
Experience of other business functions such as supply chain, finance, customer service etc.

Job Responsibility

Mitigate risk by protecting Bestway with safe and secure processes for people, stock and property
Use your knowledge and experience to drive operational excellence and consistency on store standards
Ensuring stores adhere to Coco routines and processes, influence and take responsibility where change is needed to improve on these to make better
Develop Regional plans to achieve the Business strategy and take ownership of the delivery of this
Coach the leaders in your region to deliver outstanding results for their people ensuring everyone has an opportunity to get on, is trained to carry out their role both technically and behaviourally and challenged in the right way ensuring they are treated fairly so a pipeline of talent is evident for the future with a 'spoilt for choice' mindset
Celebrate success across your teams and continually learn from missed opportunities
Build effective relationships with internal and external stakeholders using inspirational communication, effective listening, recognition, and challenge
Focus on personal growth opportunities to continuously develop yourself
Embrace change so you oversee Successful implementation, embedding and sustaining of change initiatives
Role model the need for your team to view stores through the eyes of customers and put in place consistent customer measures that are simple to follow and track

What we offer

22 days holiday plus bank holidays
Private medical
Company car
Pension

Fulltime

Medical Records Clerk

We are looking for a detail-oriented Medical Records Clerk to support healthcare...

Location

United States , Diamond Springs

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Prior experience working in a healthcare office environment is required
Familiarity with medical records processes and electronic medical record platforms is required
experience with Allscripts is preferred
Ability to maintain strict confidentiality when working with protected health information
Strong organizational skills and close attention to detail in document handling and data entry
Proficiency with Microsoft Office applications and comfort using digital record systems
Ability to manage multiple priorities effectively in a fast-paced setting
Some college coursework is preferred
Strong communication and teamwork skills to collaborate effectively with clinical and administrative staff

Job Responsibility

Oversee the organization, maintenance, and accuracy of patient files in accordance with applicable healthcare regulations and internal recordkeeping practices
Digitize, index, and upload documentation into the electronic medical record system while ensuring data is entered correctly and consistently
Respond to requests for medical documentation and prepare records for internal reviews, audits, or authorized release
Protect patient privacy by handling all records in compliance with HIPAA and established confidentiality requirements
Provide administrative support through data entry, document tracking, and general records-related clerical tasks
Coordinate with clinical personnel and office staff to resolve discrepancies and keep patient information current
Assist with ongoing records management activities and perform additional support duties as needed within the administrative team

What we offer

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

Fulltime

Senior Clinical Research Associate

As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activiti...

Location

United States

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant scientific discipline or healthcare-related field
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment
Willingness to travel as required (approximately 60%)

Job Responsibility

Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution
Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting
Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct
Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

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Senior Healthcare Regulatory Specialist (SaMD)

Job Description

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