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

Medical Affairs Specialist

The Medical Affairs Specialist will provide clinical expertise across product li...

Location

Malta , San Ġwann

Salary:

32000.00 EUR / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's Degree or Master's degree in Nursing
Masters degree or Doctorate Degree in Pharmacy, or Medical Doctor
3 to 5 years clinical experience in renal/dialysis, surgery, nutrition, or critical care
Knowledge of computer systems including Windows applications required
Strong communication, writing, analytic and problem-solving skills required
Ability to build strong relationships with internal customers
Effective interpersonal skills to work with all levels of cross functional Baxter organization and ability to work well with team members
Excellent English written and oral communication skills
Team-oriented
Self-motivated with exceptional follow through

Job Responsibility

Provide medical/clinical expertise related to use of products in the Baxter IV Access and administration pumps portfolio and related products
Maintain familiarity with the published medical literature relating to the product lines
Possess an understanding and maintain current knowledge of regulatory and quality requirements
Develop/review annual documents such as PBRERs, PSURs, CERs, RMPs, and product labeling
Develop and review quality related documents as they pertain to Baxter Pharmaceuticals products
Provide clinical support of complaint analyses
Assist Baxter’s Regulatory Affairs by providing clinical input into the evaluation and response to MOH queries
Develop expert knowledge on Baxter Clinical Nutrition and Medication Delivery product portfolio
Ensure compliance of all related clinical documents with national and international regulatory requirements and guidelines and Baxter procedures
Collaborate with medical editors to ensure documents are publication ready across functional teams

What we offer

competitive benefits
discretionary bonuses
long-term incentive

Medical Affairs Specialist

The Medical Affairs Specialist will provide clinical expertise across product li...

Location

Malta , San Ġwann

Salary:

32000.00 EUR / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's Degree or Master's degree in Nursing
Masters degree or Doctorate Degree in Pharmacy, or Medical Doctor
3 to 5 years clinical experience in renal/dialysis, surgery, nutrition, or critical care
Knowledge of computer systems including Windows applications required
Strong communication, writing, analytic and problem-solving skills required
Ability to build strong relationships with internal customers
Effective interpersonal skills to work with all levels of cross functional Baxter organization and ability to work well with team members
Excellent English written and oral communication skills
Team-oriented
Self-motivated with exceptional follow through

Job Responsibility

Provide medical/clinical expertise related to use of products in the Baxter IV Access and administration pumps portfolio and related products
Maintain familiarity with the published medical literature relating to the product lines
Possess an understanding and maintain current knowledge of regulatory and quality requirements
Develop/review annual documents such as PBRERs, PSURs, CERs, RMPs, and product labeling
Develop and review quality related documents as they pertain to Baxter Pharmaceuticals products
Provide clinical support of complaint analyses
Assist Baxter’s Regulatory Affairs by providing clinical input into the evaluation and response to MOH queries
Develop expert knowledge on Baxter Clinical Nutrition and Medication Delivery product portfolio
Ensure compliance of all related clinical documents with national and international regulatory requirements and guidelines and Baxter procedures
Includes collaborating with medical editors to ensure documents are publication ready across functional teams

What we offer

competitive benefits
discretionary bonuses
long-term incentive

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

Technical Writer & Clinical Specialist

In this role, you will be responsible for developing and maintaining technical a...

Location

Netherlands , Utrecht

Salary:

70000.00 EUR / Year

Euro London Appointments

Expiration Date

Until further notice

Requirements

Fluent English
Experience in Technical Writing or Clinical Evaluation within the Medical Device industry
Experience working with CER, PMCF or PMS documentation
Good understanding of ISO 13485, MDR and MDD regulatory frameworks
Experience preparing technical documentation for medical devices

Job Responsibility

Write, edit and maintain technical documentation related to medical device development
Contribute to Clinical Evaluation activities, including Clinical Evaluation Reports (CER) and PMCF documentation
Support Post-Market Surveillance (PMS) activities and clinical follow-up processes
Translate complex technical or scientific information into clear documentation for different audiences, including Instructions for Use (IFU)
Coordinate the review and approval of documentation with subject matter experts and internal departments
Support regulatory reporting activities, including vigilance and adverse event reporting
Participate in internal and external audits related to clinical evaluation and documentation
Contribute to risk management activities, integrating clinical and post-market data into risk management files
Perform scientific literature reviews to support clinical evaluation and regulatory documentation

What we offer

Annual bonus of 10% depending on company’s target
2 days Working From Home policy
Pension scheme Defined Benefit Plan until 2028 (transition to Defined Contribution Plan)

Fulltime

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

Clinical Affairs Specialist

Amaris Consulting

Location:

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
April 11, 2026

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