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Associate Director
Regulatory Affairs
Greater Chicago Area SUMMARY
The Associate Director, Medical
Devices Regulatory Affairs assures that the new advanced technology products are developed in line with the global registration
requirements and are expeditiously registered in a cost effective manner. In addition, guides the development staff
and the medical organization through the regulatory requirements for clinical evaluations as well as maintains registrations
of existing products in compliance with applicable regulations.
ESSENTIAL DUTIES AND
RESPONSIBILITIES
- Advises program/teams on regulatory requirements, coordinates and presents regulatory data needs,
and negotiates with and influences management, colleagues and partners to ensure regulatory data requirements are met
- Develops regulatory strategies
for advanced technology development projects. Is able to discern when features and enhancements require and do not require
registrations. Therefore, has a good understanding of software and hardware as well as the standards that apply to the
products.
- Directs clinical development through the regulatory requirements, that is, whether the study requires a non-significant
IDE, significant IDE or no registration. Identifies optimal clinical study strategies to obtain product registrations.
- Develops manufacturing improvements, and analyzes risk vs. benefit in regulatory strategies to ensure successful review
by regulatory authorities. Evaluates manufacturing changes for regulatory impact and to ensure compliance with applicable
regulations. Accurately describes these changes for ease of regulatory agency review.
- Acts as a point person for regulatory
agency interactions (either written or oral) including preparation of briefing packages and strategy for meetings, inspections,
advisory committee meetings, and responses to agency letters pertaining to the assigned products/teams.
- Prepares registration packages
and manages team to provide deliverable documents. Responds to deficiency letters. Negotiates submission data
requirements and deliverable dates with regulatory authorities and internal technical teams.
- Maintains awareness of global
regulatory legislation and assesses its impact on business and product development programs.
EDUCATION
Bachelor’s Degree required. Master’s or PhD preferred. Degree in pharmacy, biology, chemistry, pharmacology,
engineering, or related subject. A degree in a science related field will assist in problem
solving technical issues as they relate to product development, clinical evaluations, manufacture, and global registrations. EXPERIENCE AND SKILLS
- Five to eight years experience
with medical device registrations and clinical study support. Experience working directly with regulatory agencies.
Sound knowledge of applicable portions of agency guidances and regulations.
- Has international registration experience –
CE Mark, Asian, Canada and Latin America
- Has good understanding of a wide variety of technologies
- Able to challenge scientific/clinical arguments.
- Has been able to withstand FDA
challenges
- Excellent oral and written communication skills.
- Good interpersonal and negotiating skills.
- Good understanding of business
needs.
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