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Regulatory Affairs Associate, Medlogics Device Corporation (4/10/08)

Job Summary:
The Regulatory Affairs Associate is responsible for providing international and domestic regulatory support in the development and maintenance of the company's regulatory systems and medical products.

Primary Responsibilities:

• Write and manage international regulatory submissions including original clinical and Design/Drug Dossiers for international clinical and international market approvals.
• Write and manage domestic regulatory submissions including original IDE, IND, PMA, 510 (k) and NDAs for US clinical and US market approvals.
• Provide regulatory affairs input for product development and manufacturing, including review of specifications, protocols and reports, engineering changes nonconformance, product complaints, and failures.
• Obtain and distribute updated information regarding international and domestic medical device, device, and biologics regulations, guidelines and standards.
• Provide regulatory input for compliance with ISO 13485, Quality System Regulation (QSR), Drug GMP, and all other applicable requirements.
• Provide regulatory input for all clinical study requirements including Good Clinical Practice (GCP), clinical ICH guidelines and the Declaration of Helsinki.
• Develop and conduct training programs regarding company regulatory systems.
• Assist Quality Department in FDA or other regulatory agencies in case of on-site audits.
• Conduct regulatory compliance audits and develop subsequent preventive action programs.
• Maintain QSR systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production QSR compliance in coordination with the Document Control, Clinical, and Research and Development functions.
• Provide support in the rapid resolution of product complaints and/or safety issues.

Qualifications:
Education/Training

• B.S. in a scientific discipline, ideally engineering or the physical/biological sciences.
• 4+ years of biologic, pharmaceutical or medical device industry experience in regulatory affairs or an M.S. in a regulatory science or related program.  
• Class III device experience preferred.

Abilities/Knowledge/Skills

• Expertise in international and domestic device/pharmaceutical regulations
• History of successful international and domestic device/pharmaceutical submissions.
• Strong command of regulatory, quality and harmonized standards.
• Experience with GLP and GCP.
• Experience with quality system/regulatory compliance auditing
• Strong interpersonal skills to work with and lead others.
• Strong verbal and written communication, negotiation, and problem solving skills.

E-mail resumes to Joseph R. Tamayo: jtamayo@medlogicsdc.com

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