Clinical Affairs Specialist Job at Amaris Consulting (Barcelona)

Regulatory Affairs Specialist

Hemostasis, LLC designs, develops, manufactures, and markets advanced hemostat, ...

Location

United States , Saint Paul

Salary:

Not provided

Hemostasis Corp

Expiration Date

Until further notice

Requirements

Master’s degree in Regulatory Affairs and Services
Excellent written and oral communication skills
Demonstrate proactive and strategic thinking and be able to handle change and ambiguity

Job Responsibility

Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and clarification/follow-up of submissions under review
Provide technical review of data or reports that will be incorporated into regulatory submissions
Analyze validation test data to determine whether systems or processes have met validation criteria
Study product characteristics or customer requirements and confer with management to determine validation objectives and standards
Identify deviations from established product or process standards and provide recommendations for resolving deviations
Develop validation master plans, process flow diagrams, test cases, and standard operating procedures
Create, populate and maintain the database for tracking validation activities, test results and validation systems
Prepare, maintain, and review validation and compliance documentation such as engineering change notices, schematics, and technical files to obtain and sustain product approval
Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements
Prepare additional information or responses as requested by regulatory agencies

What we offer

401K
Dental
Life
Medical
Disability
Competitive salary and benefits package including health, life, retirement and related benefits

Fulltime

Medical Affairs Specialist

This position is member of the clinical science & office of medical affairs team...

Location

United States , Minneapolis

Salary:

92936.00 - 103404.00 USD / Year

Coloplast

Expiration Date

Until further notice

Requirements

5+ years’ experience within clinical research and/or medical affairs activities, preferably with medical devices
Bachelor’s degree (health science or biotech area)
Advanced degree in the health sciences preferred (MS, PhD, PharmD, MD)
Knowledge of and experience with ISO 14155, FDA, GCP, and MDR regulations
Ability to travel - 10-20%

Job Responsibility

Serve as medical expert for relevant product(s) and associated clinical conditions
Support the required clinical input into documents including, but not limited to, instructions for use (IFUs), post-market clinical plans (PMCF), clinical evaluation reports (CERs), and other relevant documents
Support development and updates of Clinical Evaluation Reports (CERs) and associated documents as assigned (i.e. CER, PMCF, SSCP, PSUR, etc)
Develop and deliver medical device technical documents supporting product launch and sustaining activities
Act as clinical representative on cross-functional product development team
Develop and deliver relevant medical device training documents (e.g. training decks, in-service scripts, eLearning tools, etc.) supporting product launch and sustaining activities
Supports with relevant medical writing expertise for evidence generation (e.g. white papers, clinical studies, publication plan, etc.). Manage publication activities, as applicable
Develop/sustain knowledge in urology, including professional conference attendance
Support Investigator Initiated Study Program (IISP) as assigned
Process and review clinical study data using Good Clinical Practices (GCP) data-handling procedures and guidelines.

What we offer

Comprehensive medical, dental, and vision insurance plans
company sponsored wellness programs and mental health resources
paid leave of absence for qualifying events
generous paid parental leave for both birthing and non-birthing parents
competitive 401(k) plan with company match that vest immediately
financial planning services
corporate discount programs for goods and services
generous paid time off
flexible work hours
flexible work arrangement options

Fulltime

Clinical Development Specialist – Diagnostics

We are seeking an enthusiastic and detail-oriented Clinical Development Speciali...

Location

Malaysia; Singapore , Kuala Lumpur; Singapore

Salary:

Not provided

ResMed

Expiration Date

Until further notice

Requirements

Bachelor’s degree in life sciences, biomedical engineering, public health, or a related field
3+ years of experience in clinical development or clinical research, with a focus on diagnostics, in vitro diagnostics (IVDs), or medical devices
Familiarity with clinical validation and usability studies for diagnostics
Working knowledge of Good Clinical Practice (GCP), ISO 14155, and diagnostic regulatory frameworks
Strong organizational skills and the ability to manage multiple projects simultaneously
Excellent verbal and written communication skills
Highly skilled in stakeholder management across different regions and time-zones

Job Responsibility

Support the planning and execution of clinical studies—including analytical validation, clinical validation, and usability studies—aligned with diagnostic development goals
Assist in developing study protocols, investigator brochures, case report forms (CRFs), and other clinical study documents
Collaborate with internal stakeholders such as Regulatory Affairs, Clinical Operations, R&D, and Marketing to ensure integrated study planning and execution
Liaise with external investigators, clinical sites, and contract research organizations (CROs) to support effective study conduct and data integrity
Participate in data analysis and interpretation activities to support product development, regulatory submissions, and scientific communications
Track study timelines, milestones, and budgets to ensure clinical projects are completed on time and within scope
Maintain a strong understanding of diagnostic regulatory pathways (e.g., FDA, CE-IVD, CLIA) and ensure compliance with applicable clinical and ethical guidelines
Contribute to the development of abstracts, posters, and manuscripts to communicate clinical evidence to external audiences

Fulltime

New

Clinical Integration Specialist

As a Clinical Integration Specialist within Resmed’s Medical Affairs Clinical Co...

Location

Malaysia , Kuala Lumpur

Salary:

Not provided

ResMed

Expiration Date

Until further notice

Requirements

Minimum: Bachelor’s degree in science or clinical field
Strong clinical/academic background required
Experience in working with or deep understanding of published clinical research
Experience in literature searches and clinical content, with ability to provide intelligent summary of findings
Independent individual contributor
Proficient at driving projects to completion, at times working remotely with a global team (different time zones involved)
Working knowledge of Microsoft Office (World, Excel, PowerPoint), Outlook, Teams and SharePoint
Strong appetite for technology solutions and interest in GenAI platforms to support process and department improvements

Job Responsibility

Manage marketing material review workflows for Medical Affairs, including review of content for clinical accuracy
Support process management of material review needs for Medical Affairs for both external and internal materials
Support the build of systems and processes to ensure the Clinical Integration team can grow with scale with Resmed’s needs
Understand Resmed’s products and services for clinical application to actively and effectively conduct literature searches as applicable to the role
Learn about software tools for scientific publications in order to assist users in their requests for information, including purchasing articles if required, creating bibliographies and research folders for particular subjects
Update and organise the knowledge management training materials for users to help make training easy and accessible to a range of users
Proactively identify areas of efficiency and/or productivity improvement for knowledge management services to the medical affairs organization
Be prepared to provide regular progress updates to direct manager(s), with opportunity to present project updates to larger Medical Affairs teams
Manage central repository of content created by MA personnel (Claims repository and Sharepoint)
Support communication of Medical Knowledge platforms and updates to broader MA organization

What we offer

Contribute to meaningful work that helps improve patients’ lives and transforms healthcare delivery
Collaborate with diverse, global teams in a dynamic and supportive environment
Access continuous learning and professional growth opportunities

Fulltime

New

Sr Director, Medical Affairs

The Senior Director, UCAN Medical Affairs guides strategic and operational initi...

Location

United States , Deerfield

Salary:

224000.00 - 308000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Advanced degree (MD, PharmD, PhD, or equivalent scientific/clinical doctorate)
10+ years of experience in Medical Affairs, Clinical, or Scientific roles within medical devices, pharmaceuticals, or combination products
Proven leadership of downstream and field-based medical organizations across complex portfolios
Deep understanding of medical governance, compliance, and scientific engagement in regulated environments

Job Responsibility

Own and complete the downstream Medical Affairs strategy across Infusion Systems, IV Solutions, Clinical Nutrition, and Pharmacy products, aligned to regional and global medical objectives
Convert upstream medical strategy, clinical data, and evidence generation plans into tactical downstream medical plans that support launches, line extensions, lifecycle management, and in-market optimization
Ensure scientific and medical differentiation is clearly articulated and appropriately embedded across customer-facing medical activities
Lead and develop Field Medical teams (e.g., MSLs, clinical specialists) supporting downstream portfolios, ensuring consistent implementation, scientific rigor, and compliant HCP engagement
Coordinate Key Opinion Leader (KOL) strategy, including identification, engagement planning, and insight generation across therapy areas
Guide planning and execution of advisory boards, investigator meetings, educational forums, and non-promotional scientific exchanges
Responsible for scientific communication strategies supporting downstream portfolios, including data dissemination, congress strategy, and educational initiatives
Ensure accurate, balanced, and compliant communication of clinical evidence to internal and external collaborators
Collaborate with Medical Information, Clinical Development, and Global Medical teams to maintain uniformity in scientific narratives
Serve as the senior downstream medical partner to Commercial, Downstream Marketing, Sales, Training, Market Access, and Commercial Operations

What we offer

Medical and dental coverage starting on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

New

Sr Director, Medical Affairs

The Senior Director, UCAN Medical Affairs guides strategic and operational initi...

Location

United States , Deerfield

Salary:

224000.00 - 308000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Advanced degree (MD, PharmD, PhD, or equivalent scientific/clinical doctorate)
10+ years of experience in Medical Affairs, Clinical, or Scientific roles within medical devices, pharmaceuticals, or combination products
Proven leadership of downstream and field-based medical organizations across complex portfolios
Deep understanding of medical governance, compliance, and scientific engagement in regulated environments
Applicants must be authorized to work for any employer in the U.S.
We are unable to sponsor or take over sponsorship of an employment visa at this time

Job Responsibility

Own and complete the downstream Medical Affairs strategy across Infusion Systems, IV Solutions, Clinical Nutrition, and Pharmacy products, aligned to regional and global medical objectives
Convert upstream medical strategy, clinical data, and evidence generation plans into tactical downstream medical plans that support launches, line extensions, lifecycle management, and in-market optimization
Ensure scientific and medical differentiation is clearly articulated and appropriately embedded across customer-facing medical activities
Lead and develop Field Medical teams (e.g., MSLs, clinical specialists) supporting downstream portfolios, ensuring consistent implementation, scientific rigor, and compliant HCP engagement
Coordinate Key Opinion Leader (KOL) strategy, including identification, engagement planning, and insight generation across therapy areas
Guide planning and execution of advisory boards, investigator meetings, educational forums, and non-promotional scientific exchanges
Responsible for scientific communication strategies supporting downstream portfolios, including data dissemination, congress strategy, and educational initiatives
Ensure accurate, balanced, and compliant communication of clinical evidence to internal and external collaborators
Collaborate with Medical Information, Clinical Development, and Global Medical teams to maintain uniformity in scientific narratives
Serve as the senior downstream medical partner to Commercial, Downstream Marketing, Sales, Training, Market Access, and Commercial Operations

What we offer

Medical and dental coverage starting on day one
Basic life insurance
Accident insurance
Short-term disability insurance
Long-term disability insurance
Business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
Educational assistance programs

Fulltime

Medical Affairs Specialist

MagVenture A/S is expanding and therefore, we are seeking to recruit a colleague...

Location

Denmark , Farum

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Master of Science degree, maybe complemented with a PhD or other types of research/clinical experience
Previous experience as a medical/scientific writer of clinical and regulatory documents, is a plus, but not a requirement
A critical, scientific mindset with a thorough understanding of research methodology, including statistical methods, study design and research concepts
Strong analytical and communication skills
Excellent written and verbal communication skills in both Danish and English
Structured, result-oriented, committed and can handle changes in prioritization of tasks
Thrive in a smaller company where you need to follow projects from one end to the other and contribute to an open and dynamic collaboration with your colleagues, from many different functional areas

Job Responsibility

Drive and maintain Clinical Evaluation Reports (CERs) on our existing portfolio to meet the requirements of the Medical Device Regulation (MDR) and other regulatory bodies
Develop, plan, and write CERs for new indications for use and/or new products
Handle and evaluate Post-Market Information data on an ongoing basis
Write and update Periodic Summary Update Reports (PSUR)
Provide input and support to development projects as well as other regulatory documents, like ‘Instructions for Uses’, usability reports, clinical risk documentation, etc.

What we offer

Flex time
Pension
Canteen
Health insurance
A newly built, super nice office in Farum

Global Category Manager – Clinical

Global Category Manager - Clinical / Direct Procurement for Pharma, Healthcare &...

Location

Spain , Madrid

Salary:

55000.00 - 65000.00 GBP / Year

Bramwith Consulting

Expiration Date

Until further notice

Requirements

Proven experience in clinical or R&D procurement within pharmaceuticals, biotech, healthcare or related regulated sectors
Hands-on experience managing RFP/RFI cycles, rate cards, master service agreements (MSAs), scope of work (SOW) development, and contract execution with clinical vendors or CROs
Ability to conduct market analysis, benchmark service offerings, and manage supplier performance using defined KPIs
Strong cross-functional stakeholder engagement with teams such as clinical operations, regulatory affairs, QA, finance, legal, and technical/scientific functions
Confidence working with structured reporting, savings tracking, documentation standards, and procurement systems (e.g. Ariba, contract management workflows, dashboards)
A mindset for process improvement, simplification, and bringing consistency to sourcing documentation, templates, and workflows
Relevant qualification (CIPS or equivalent) beneficial

Job Responsibility

Drive sourcing excellence
Work closely with R&D, clinical operations, legal, finance, regulatory and quality teams to shape category strategies, strengthen supplier relationships, and embed consistent sourcing standards and documentation
Influence category strategy, implement sourcing frameworks, and standardise processes across areas such as: Clinical trial services, full-service CROs and specialist providers
Biomarker, central laboratory and bioanalytical services
Lab equipment, consumables, and scientific technology
Packaging, materials, and external manufacturing partners
Drive both commercial value and risk/compliance outcomes, including GxP alignment, audit readiness, and service quality
Opportunity to contribute to project governance, reporting, dashboards, benchmarking initiatives, templates, process descriptions, and continuous improvement projects

What we offer

Package

Fulltime

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Clinical Affairs Specialist

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