Leadership in the cardiology industry in this century will be based on a core competency in biologics. Bioheart, Inc. is developing cell based therapies for treating heart failure and other cardiovascular diseases.

Bioheart, Inc. is currently expanding and seeks to hire qualified individuals in the following areas to work at our headquarters in South Florida:

• Clinical Research Manager (CRM)
• Regulatory Specialist
• Laboratory Technician

Please email your resume to our Director of Administration
and Human Resources, Ms Catherine Sulawske-Guck at:

csguck@bioheartinc.com

Bioheart, Inc. is an equal opportunity employer

Bioheart, Inc. currently has an opening for...

Clinical Research Manager (CRM)

Job Description/Responsibilities:

The Clinical Research Manager (CRM) is responsible for supporting the Manager, Clinical Affairs and managing specific projects within the Clinical Affairs department. The position requires communication and coordination with physicians, clinical sites, research organizations, and potential patients.

Duties For This Position Include The Following:

• Coordinate with clinical sites to make sure clinical studies operate in an efficient manner
• Create clinical reports and powerpoint presentations
• Manage internal databases
• Provide technical support and training to domestic and foreign clinical sites
• Coordinate with Contract Research Organizations with regard to clinical trial operations and manage timely completion of all pending issues regarding the clinical trials
• Coordinate with Regulatory Affairs and aid with the submission processes and timely collection of documents necessary to initiate clinical trials and satisfy general filing requirements
• Monitor and collect data from domestic and foreign clinical sites in accordance with GCP and SOPs
• Perform audits of clinical sites and external vendors
• Organize and facilitate Investigator and Monitor Meetings, Site Initiations and other clinical meetings
• Assist QA in complaint handling
• Maintain the day to day clinical affairs operations through constant contact with the CRO's as well as clinical sites and Bioheart personnel
• Assure investigators get all documents necessary for the consistent operation of the clinical trials
• Assist in overseeing and maintaining control of the clinical trials and planning for future clinical trials

Minimum Qualifications:

• BS Degree in Nursing or the equivalent thereof
• Minimum 3 years experience in related field
• GCP and ICH/FDA knowledge
• Nursing background preferred
• Experience with start-up biotech or biomed company preferable

Travel Requirements:

U.S. and International travel may be required for 25% of work time

Interested candidates should submit their resume to csguck@bioheartinc.com.

Bioheart, Inc. currently has an opening for...

Regulatory Affairs Specialist

Job Description/Responsibilities:

The Regulatory Affairs Specialist has responsibility for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. This position will report to the Vice President, Clinical Affairs & Physician Relations.

Duties For This Position Include The Following:

• Develop and execute U.S. and international regulatory strategies.
• Develop and execute Partial Reimbursement Clinical Trial strategies.
• Establish and maintain Bioheart’s relationship with regulatory agencies, including U.S., foreign and Bioheart’s selected Registrar/Notified Body.
• Clearly define the regulatory requirements necessary for regulatory approval to commence clinical trials or to gain approval for commercialization, help shape clincial protocols and submit final reports to regulatory agencies. Work closely with VP of Clinical Affairs & Physician Relations in all of these duties.
• Ensure regulatory compliance with all applicable regulations with goal to gain full approval for commercialization in as many markets as possible as supported by the clinical data and filings. This includes gaining the regulatory approvals necessary to enter partial reimbursement clinical registry trials OUS.
• Ensure compliance of Bioheart’s Quality System to all applicable ISO 9001/EN 46001, FDA Quality System Regulation cGMP requirements and any other applicable biologics regulations.
• Support the efforts of Bioheart’s Biologics Division and Clinical Department as required.
• Ensure safety of all patients treated with our products and assist with all regulatory filings in this regard.
• Keep documents organized and ready for audit and ready for regulatory filings when required ie; an updated (general) foreign regulatory submission package should be ready to send upon request at all times.
• Support team activities and assume responsibility for activities, as necessary, to fulfill company needs.
• Ensure the quality, content and format of regulatory submissions.
• Ensure consistency, completeness and adherence of standards for all submissions.
• Serve as the regulatory affairs representative on project teams.
• Review and evaluate information relevant to the safety of Bioheart’s investigational products.
• Coordinate and consult with other departments on the content, review and assembly of regulatory documentation.
• Manage regulatory project timelines in accordance with project, department and corporate goals.
• Assist with the review of promotional materials.
• Assist with regulatory compliance in the event of product recall.

Minimum Qualifications:

• B.S. in a scientific discipline, ideally engineering or the physical/biological sciences (M.S. or Ph.D. preferred).
• 3+ years of biologic, pharmaceutical or medical device industry experience in regulatory affairs.
• Thorough understanding of both domestic and international regulatory requirements.
• Strong verbal and written communication, negotiation, and problem solving skills.

Interested candidates should submit their resume to csguck@bioheartinc.com.

Bioheart, Inc. currently has an opening for...

Laboratory Technician

Job Description/Responsibilities:

Reporting to the Director, Cell Process Development and R&D or his/her designate. Conduct studies involving the isolation, expansion, and characterization of skeletal myoblasts. Responsible for following and maintaining SOPs relating to both clinical and pre-clinical studies. Responsible for accurate and organized record keeping and filing of lab related information.

Duties For This Position Include The Following:

• Culture and maintain skeletal myoblasts and/or other types of cells as needed
• Maintain cell culture binders and paperwork
• Perform appropriate quality control tests on cells
• Communicates test results to the responsible parties
• Operate and maintain laboratory equipment
• Maintain a laboratory notebook
• Maintain and follow Standard Operating Procedures and/or Batch Production Records
• Perform general laboratory duties (ordering supplies, etc.)
• Maintain laboratory supplies and shipping/receiving logs

Minimum Qualifications:

• Associate degree in science or equivalent. Laboratory professional with experience and ability to understand and learn procedures.
• Ability to keep proper records and enter data into spreadsheets is required. Previous laboratory experience is desired.
• Knowledge of GMP/GLP environment is also desired.
• Training will be provided for all procedures and safe laboratory practices.

Interested candidates should submit their resume to csguck@bioheartinc.com.