New · posted Nov 13
Artivion · Medical Devices
Principal Clinical Research PM
- Kennesaw, GA
- On-site
- Full-time
- Senior & Principal
The role
Manage assigned departmental projects and tasks in principle areas of responsibility, which are identified below for aortic arch repair technologies, including execution of investigational device exemption (IDE) studies.
What you need
- Minimum of a Bachelor’s degree, preferably a Master’s degree (in a related field).
- Minimum 10 years’ experience in clinical research or relevant experience, or advanced degree with 8 years’ experience.
- Experience with aortic repair technology (i.e. surgical grafts, endovascular devices) is highly desirable.
- Experience working on IDE studies is highly desirable.
- Experience working at a medical device company is highly desirable.
- Demonstrate project management, critical thinking, and communication skills.
- Demonstrated statistical and computer skills (spreadsheet, relational databases, intermediate to advanced statistical analysis).
- Excellent written and oral communication skills.
- Proficient knowledge of medical terminology.
- Willingness to travel.
What you'll do
- Serve as the primary owner of clinical studies, independently overseeing all study activities including stakeholder communication, team leadership, timeline execution, budget management, and issue resolution.
- Act as the main point of contact for assigned studies, leading cross-functional study team meetings and driving accountability across internal and external partners.
- Manage all study vendors, including qualification, onboarding, contract and budget oversight, invoicing, and escalation of operational issues.
- Develop clinical strategy for investigational device exemption (IDE) studies.
- Participate as a core team member, specifically collaborating with Regulatory, Quality, R&D, and Commercial stakeholders.
- Oversee day-to-day site operations at clinical sites to ensure clinical trials are conducted in compliance with protocols, contracts, GCP, and applicable regulatory requirements.
- Lead the development, review, and maintenance of clinical documentation, including protocols, study management plans, informed consent forms, case report forms, SOPs, and study amendments.
- Manage qualification, selection, and operations of study steering and safety committees.
- Plan and support quality initiatives to ensure study readiness for data analyses.
- Support the development of abstracts, manuscripts, and scientific presentations by coordinating with investigators and co-authors.
- Ensure timely preparation and completion of clinical study reports in alignment with regulatory and organizational deadlines.
- Develop and deliver study-related presentations for internal and external audiences.
- Interface with technical representatives, regional managers, and research teams to provide technical training and address clinical or customer-related inquiries.
- Facilitate regulatory submissions, including annual FDA reports and other required regulatory documentation.
- Serve as a reviewer for technical and marketing materials to ensure scientific accuracy and regulatory compliance.
- Collaborate with Quality and Risk Management partners to proactively identify, assess, and mitigate device risks.
- Support site recruitment and selection activities, investigator meetings, and site training initiatives.
- Perform basic statistical analyses to support product lines and clinical decision-making.
- Conduct literature reviews and prepare scientific summaries relevant to product development and clinical strategy.
- Attend national and international surgical and scientific congresses, in person or remotely, as required.
- Perform additional responsibilities, including duties executed at a level above current title, as assigned.
Where you'll work
Kennesaw, GAOn-siteOpen in Maps (opens in a new tab)
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From the posting
About Artivion
Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with aortic diseases. Artivion’s four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion has over 1,600 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com.
Job intelligence
The context around this role
Live data · November 13, 2026
Career trajectory
Where this role sits in Clinical Project Management
The general path across 44 open Clinical Project Management roles on Regulatory Jobs, with the titles they carry most. Not Artivion's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 32 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Clinical trial conduct7
- Investigations and CAPA4
- Documentation and SOPs3
- GMP and compliance2
- Validation and qualification2
- Regulatory submissions1
- Quality systems and risk1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Project Management work in medical devices, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 812(official source, opens in a new tab)Investigational device exemptions for clinical studies of devicesNamed in the posting
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- ISOISO 14155(official source, opens in a new tab)Good clinical practice for clinical investigations of medical devices
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- EUMDCG guidance(official source, opens in a new tab)The Medical Device Coordination Group's endorsed guidance on applying the MDR and IVDR
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- FDAFDA Q-Submission Program(official source, opens in a new tab)Pre-Submissions and meetings with FDA on device submissions
Company hiring pulse
Artivion on Regulatory Jobs
- 12
- Open roles
- 12
- Distinct roles
- 2
- Locations
By discipline
- Clinical5 42%
- Quality4 33%
- Regulatory3 25%
By level
- Senior & Principal5 42%
- Associate & Specialist4 33%
- Manager2 17%
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Principal Clinical Research PM at Artivion
Open until filled.