Medical Affairs Specialist Job at Baxter (San Ġwann)

Junior Regulatory Affairs Specialist

Junior Regulatory Affairs Specialist of Cosmo Intelligent Medical Devices.

Location

Italy , Rome

Salary:

Not provided

Cosmo Intelligent Medical Devices

Expiration Date

Until further notice

Requirements

Bachelor’s degree in engineering, science or related scientific discipline, or equivalent
Minimum of 2 years of experience in regulatory affairs roles within the medical devices or healthcare industry
English proficiency at professional level
Professional knowledge of Reg. (EU) 2017/745 and Title 21 CFR parts 800-898 and technical standards ISO 13485, ISO 14971
Practical understanding of scientific and technological aspects related to software, computer engineering, artificial intelligence, and endoscopy
Strong analytical skills with a detail-oriented approach
Ability to work independently and collaboratively across multifunctional teams
Highly dynamic and adaptable to a fast-moving and innovative environment

Job Responsibility

Assess, prepare, and manage technical documentation to support certification and submission processes in the European Union and U.S.A
Prepare and manage technical dossiers for submission in other countries according to local regulations and guidance documents
Cooperate with other departments to the creation and update of technical documentation needed according to country requirements
Assist external stakeholders in the regulatory process per country requirements
Maintain and update certifications, registrations, and renewals as required by country regulations and assess regulatory impact of medical device changes with respect to country requirements
Cooperate to the management of documented material and communications with Competent Authorities, Certification Bodies, and other stakeholders according to the given regulatory aspect
Cooperate to the management of company regulatory procedures by timely awareness and implementation of changes due to the development in the regulatory landscape
Assist in internal and external audits and provide regulatory input to optimize company compliance and minimize the possibility of non-compliance findings
Promote the culture of compliance by proactively interacting with all departments and by provision of trainings
Cooperate to the development of new activities, adapt to new challenges and opportunities, and take on new duties stemming from the development path of company activities

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

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

Quality Assurance Specialist, Medical Communications

Location

India

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experienced Medical Writer (1-2 years)
Scientific background and degree (PharmD, MD, PhD or Masters)
Knowledge of IT and digital solutions
Strong attention to detail and accuracy
Ability to manage and prioritize multiple, detailed activities
Results-orientated with fast and focused execution
Good communication, coordination and time management skills
Ability to work within a team or across multiple teams (including remotely) as well as independently
Fluent in oral and written English with high level of communication skills
Values teamwork, collaboration, and innovation

Job Responsibility

Cross check scientific information against cited references and ensure medical accuracy (fact check)
Ensure consistency with product label where applicable
Verify presence of essential information
Correct interpretation of scientific data from reference/sources
Alignment/formatting of content as per style guides/journal guidelines/congress guidelines
Ensure consistency of scientific content across different sections (including text, figures, tables)
Accurate bibliography/in-text citation and alignment of figures/graphs as per branding guidelines
Confirm that every sentence is source annotated, and each source annotation matches with respective reference and vice versa
Ensure that information is presented in a neutral manner without any interpretations and/or author’s conclusion
Track work and communicate with client team on job reviews, prioritization etc., through emails and teleconferencing if needed

Data Entry Specialist

The Data Entry Specialist is responsible for collecting payer policies for speci...

Location

United States , Oradell, NJ

Salary:

Not provided

Accreditation Council for Medical Affairs (ACMA)

Expiration Date

Until further notice

Requirements

Bachelor's degree or currently enrolled in a bachelor's program
Strong computer skills, including proficiency in Microsoft Excel
Excellent attention to detail and accuracy
Ability to work independently
Ability to meet deadlines and handle multiple tasks simultaneously

Job Responsibility

Collect payer policies for specific medications from various payer or medication websites
Download and clean policies following our criteria
Upload the cleaned policies to a backend application and the company drive
Maintain accurate records of all downloaded and uploaded documents
Troubleshoot any technical issues that may arise during the data entry process
Communicate with the tech lead specialist and other team members as needed

What we offer

Flexible, remote work environment
Opportunity to contribute to high-impact educational programs that set industry standards
Collaborative and mission-driven team focused on advancing medical affairs professionals globally

Fulltime