Senior Clinical Affairs Specialist-Remote Ireland

Integer; Jonesboro (TX); Remote; USD 90,000 - 120,000; Full time

Job summary

A leading medical device company in Jonesboro is seeking a Clinical Affairs professional to develop global clinical strategies and ensure regulatory compliance. The ideal candidate has over 5 years of experience in the medical device industry and a relevant degree. Responsibilities include representing the Clinical Affairs function on product development teams, generating reports, and supporting clinical trials. This role offers the opportunity to advance your career in a collaborative work environment.

Benefits

Career advancement opportunities

Supportive work environment

Engagement in innovative projects

Qualifications

• Minimum of 5 years of experience in the medical device or pharmaceutical industry.
• Experience with US and international medical device regulatory submissions.
• Ability to generate reports as the first author.

Responsibilities

• Develop global clinical strategies for product submissions.
• Represent the Clinical Affairs function on product development teams.
• Support the development of Integer technology objectives and budget management.

Skills

Clinical strategy development

Regulatory compliance

Clinical trial monitoring

Collaborative work

Education

Degree in Science, Engineering, Health Science, Nursing, or related field

Job description

Employer Industry: Medical Device and Pharmaceutical Industry

Why consider this job opportunity:

• Opportunity for career advancement and growth within the organization
• Supportive and collaborative work environment
• Engage in innovative projects that directly impact product development
• Opportunity to work with regulatory bodies to facilitate approvals
• Involvement in clinical training initiatives and investigator conferences

Responsibilities

• Develop global clinical strategies for product submissions and support post-submission activities
• Represent the Clinical Affairs function on product development teams and ensure compliance with regulatory requirements
• Generate interim and final reports as the first author
• Monitor clinical trials and provide clinical perspectives on field complaint investigations
• Support the development of Integer technology, including objectives, strategy, and budget management

Qualifications

• Degree in Science, Engineering, Health Science, Nursing, or a related field
• Minimum of 5 years of professional experience in the medical device or pharmaceutical industry; 10 years if a degree is not a prerequisite
• Experience with US and international medical device regulatory submissions and approvals
• In-depth knowledge of medical device regulations and quality system requirements
• Proven ability to work independently and collaboratively across the organization

Preferred Qualifications

• Experience with implantable devices or high-risk device types
• Familiarity with research methods, systematic literature reviews, and medical writing
• Experience with feasibility, pivotal, and post-market clinical trials
• Knowledge of current FDA, ISO, and related quality and regulatory systems
• Proven track record in planning and executing clinical evaluations autonomously

#MedicalDevices #ClinicalResearch #Innovation #RegulatoryCompliance #CareerGrowth

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