Regulatory Affairs

Director/VP - Regulatory Affairs & Quality Assurance

Position Objective

Quadraspec is located in West Lafayette, Indiana in the center of the nationally acclaimed Purdue University Technology Park. We are currently looking for a Director/Vice President of Regulatory Affairs. This position will report to the COO and will be responsible for the overall regulatory affairs strategy and execution. This role will be instrumental in providing leadership for regulatory efforts to support U.S. and International In-Vitro Diagnostic Medical Device regulatory activities.

Essential Functions

Direct all regulatory affairs activities related to product/device development and approval.
Develop and maintain regulatory affairs infrastructure including developing departmental policies and procedures.
Identify, develop, and implement appropriate regulatory strategies including submission strategies to support product development and approval for various medical device products
Create and maintain regulatory affairs submission timelines and charts.
Successfully influence cross-functional disciplines including Pre-clinical, and Clinical Development, Technical Operations, QA, QC, Engineering, New product Research & Marketing.
Develop strategies to identify and implement activities to support project goals, milestones, corporate goals and objectives.
Prepare/coordinate device regulatory submissions (510(k), PMA, CE marking, etc.).
Interact with regulatory authorities on project-related issues, regulatory policies, and other relevant issues.
Lead Quadraspec in understanding/awareness of US and international regulatory requirements.
Create appropriate timelines, goals/objectives and budgets.
Influence partners with respect to strategies and critical issues to positively affect project goals, objectives and ultimately product approval.
Plan, arrange, and conduct health authority meetings (Pre-IND, End-of-Phase 2, Pre-NDA, MHRA Scientific Advice meetings, etc.) and manage all regulatory communications.
Participate in the corporate business development efforts, particularly in providing guidance and input regarding the potential impact of future international regulations.
Oversee cGCP compliance activities internally and externally.
Support the product development team with regulatory input on next generation products

Requirements

BS/BA degree minimum, Masters degree preferred.
Minimum of 7-10 years experience in direct management of regulatory affairs
Global/International experience desired.
Excellent understanding of the U.S. In-Vitro Diagnostic/Medical Device regulatory affairs, Submissions, Technical Files, cGMP/Quality Systems, Compliance and Import/Export regulations.
Direct experience in communicating with Regulatory Authorities and Distributors.
Demonstrated success in development of regulatory strategies.
Proven leadership in compliance with respect to FDA regulations and guidelines related to clinical strategy, GCPs, GLPs, SOPs, submissions, product launch, labeling, advertising and promotion, and medical device reporting
Hands on experience with clinical research studies for Class III devices.
Demonstrated success in building and managing Regulatory Affairs departments
Ability to function in a small company, "hands-on" environment
Strong written, verbal, and presentation skills, including the ability to present, persuade and convince regulators, and key leaders with respect to the company's products and clinical/regulatory strategies
Advanced knowledge of regulatory requirements for PMAs, Annual Reports, and promotional materials
Strong working knowledge of medical procedures, drug therapies, statistical concepts and data collection, reporting and computerization of data collected in clinical trials.

Must have the capability to discuss statistical aspects of studies with investigators, medical directors, and regulatory authorities, and possess skills and knowledge for project planning/management/control, budget management, etc.

Ability to review, understand, and explain the appropriate FDA guidance documents to team members.
Ability to drive meetings with various stakeholders.
Experience with common continuous improvement tools a plus (e.g., agile scrum, six sigma, SPC).
ISO 13485 Quality System/US GMP a PLUS
Excellent written, oral, organizational, and interpersonal skills are required.
Must live or be willing to relocate within reasonable commuting distance of West Lafayette, Indiana.

Please send resume and cover letter if available to jobs@quadraspec.com. Your subject line should read "Regulatory Affairs . ”