ESSENTIAL JOB FUNCTIONS / RESPONSIBILITIES:
The Medical Device Regulatory Affairs Specialist (MDRAS) shall be a subject matter expert in MD regulatory requirements for, GXP compliance, DFX – design control and management, creation and submission of all regulatory communications and approval documentation packages and client and Agency management of the regulatory submission and approval process. A successful MDRAS will be experienced in recognizing client needs for the services they are responsible for and selling that expertise in collaboration with the rest of the PAI Management.
This individual may be the project executive and lead expert on projects where they have the most experience in the field. Along with being the lead person for a project, the MDRAS will also be responsible for ensuring that information about the client-firm is correct, and the current project proposal is being proposed in the proper way to ensure complete fulfillment of the client’s needs.
An MDRAS will be responsible, along with the President and Sphere Leaders for identifying and promoting the Regulatory Affairs sphere of services. This individual will provide area expertise as related to the specific client project success metrics and must possess the maturity and temperament to assist in guiding the client and project to a successful outcome. They will need to ensure that their own team has completed the proposed scope of work within the prescribed estimates given the assumptions for the program.
The MDRAS will be required to stay abreast of all regulatory elements pertinent to developing, filing and commercializing a medical device or combination product in the US and EU as well as any universally recognized industry best practices, standards and regulations. This position will be expected to write and publish articles and white papers on current regulatory compliance, warning letters and consent decree trends and subjects that the life sciences industry is interested in learning about. Additionally, they will prepare training programs and provides guidance that addresses the client’s medical device compliance and business needs. Additional specific activities which are within the scope of this position include: Conducts domestic and International MD compliance audits, due diligence audits, including mock-FDA audits and assists with remediation activities to obtain compliant quality systems.
Assess issues and implements quality systems tailored to the size and maturity of the client and that will pass regulatory agency scrutiny.
Provide CE Mark, MDR and IVDR guidance for Europe
Directs and designs MD compliance initiatives (CAP-Corrective Action Plans) to remediate quality systems for Executive Management and provides oversight during implementation.
Provides oversight and direction to client’s upper management regarding regulatory compliance and helps client to execute corrective action plans.
Provides 483, warning letter, consent decree and strategic regulatory consultation.
Provides input on regulatory documents such as MAF, 510K (both Standard and DeNovo) and Pre-Market Approval (PMA) submissions for all medical devices including but not limited to: IVD, Companion Drug products, Nxt Gen Gene Sequencing and Combination Drug Devices.
Will participate with clients as an advisor or participant in the highly stressful back rooms during Agency audits while, at the same time and where appropriate, mentoring individuals involved in the audit process.
Works with client’s executive management by; advising and writing responses to FDA-483s, Warning Letters, Consent Decrees and interacting directly on the client’s behalf with the Agency.
The MDRAS reports to the President and Chief Scientific Officer and is responsible for identifying areas of opportunity related to the company’s MD regulatory affairs and compliance service offerings and identifying and coordinating resources for managing the organization’s day-to-day regulatory compliance consulting activities.
Must be able to effectively interact with the executive management team members, staff, consultants, administrative, HR and accounting services personnel. The MDRAS provides leadership and direction to meet the strategic objectives of the organization and ensures quality of services, cost effective services, and profitability of the MD regulatory affairs compliance consulting services. He also provides ongoing cross-training of internal resources in medical device regulatory affairs compliance.
Bachelor Degree in the Engineering Sciences or BME Life Sciences.
Minimum of 5+ years of experience medical device development regulatory approvals, 5+ years’ industry experience in pharmaceutical/biotech QA Compliance, and 5+ years of MD regulatory affairs and or compliance consulting is desired.
REQUIRED SKILLS / QUALIFICATIONS:
The MDRAS shall possess strong leadership and experience in a successful & profitable regulatory affairs compliance consulting practice.
The MDRAS must be able to build and maintain relationships with Pharmatech’s executive management & the rank and file and communicate effectively across the entire organization. Must be able to effectively communicate to various audiences, including the senior management. Implements and defends management strategies and decisions.
PERSONAL TRAITS: Must be articulate, organized and communicates well at all levels of management. Highly reliable and efficient at organizing and completing project tasks and reports.
PHYSCIAL REQUIREMENTS: Must be able to sit for long periods of time and lift a minimum of 30 pounds.
TRAVEL REQUIREMENTS: This is a remote position. Travel requirements will be project specific but typically will average 25% to client sites anywhere in the US or internationally.
UTILIZATION REQUIREMENTS: Must be 70-75% billable.