"Alerted.org

Position Overview

MCRA, an IQVIA business is seeking a Vice President, Spine Regulatory Affairs to be a critical team member and Company leader supporting regulatory strategy and submissions for the firm’s spine clientele. The primary roles and responsibilities include managing the development of regulatory submissions, development of overall regulatory strategy, and communicating with regulatory bodies and clients. VPs also manage various personnel during various projects, as well as act as a mentor and trainer for junior employees while supporting business development efforts with prospective clients and maintaining healthy relationships with preferred vendors.

Position Responsibilities

Manage and grow department/team, including budgets, client relationships, employee training and development, hiring, and business development, as required.

Develop and execute regulatory services for client companies, including, however not limited to:

Regulatory Submissions (e.g., 510(k), IDE, PMA, De Novo, IND, BLA, IND, Technical Documentation, STED, CERs) Regulatory Strategy, Analysis & Development

Design, Review & Implement Non-Clinical Testing

Design, Review, and Support Implementation of Clinical Trials

Manage Regulatory Affairs staff across multiple services and/or domains, facilitate professional development, and ensure regulatory projects are completed in an accurate and timely manner.

Leads prospecting of the organization and is known externally for thought leadership in area of expertise

Lead/manage business development functions to secure new clients and projects

Work directly with client companies and/or regulatory bodies as primary contact.

Provide project leadership on complex regulatory projects while maintaining sole relationships with client companies.

Lead people development projects, working alongside team managers, as required.

Collaborate with other MCRA departments, including clinical, RHEMA, compliance, and quality assurance.

Collaborate with other department heads and executive management to guide the progress and development of the regulatory department and company, as required.

Required Qualifications

Bachelor’s degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred.

Minimum fifteen years of experience in Regulatory Affairs related to development of medical devices, drugs and/or biologics, developing regulatory deliverables and submissions. Work experience must include project management.

Minimum of three to five years of experience managing people related to regulatory affairs or biomedical research and development projects.

Federal regulatory agency experience is preferred.

Direct experience in one or more of the following device areas: introcolumnar spinal devices, extracolumnar spinal devices, or non-fusion spinal devices.

Experience with leadership responsibilities for numerous projects and functioning as primary contact for regulatory bodies and clients.

An understanding of clinical research and data analysis is required.

Possesses US and/or spinal regulatory experience/fluency with regulations (e.g., FDA, Notified Body, ISO 13485).

Domain-specific regulatory expertise in a therapeutic area or other MCRA areas of regulatory and scientific expertise.

Strong attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.

Possesses strong written, including medical/technical writing, and verbal communication and presentation skills.

Possesses an understanding of engineering and a biological background to assist with pre-clinical and clinical strategies and is able to effectively communicate these strategies to internal team members and clients.

Strong research, analytical, critical-thinking and problem-solving skills.

Strong professionalism with customer relations and managing client relationships.

Ability to lead small or large teams effectively, mentor junior team members, and is accountable for team reaching target utilization, as required.

Able to lead multiple projects with competing deadlines; takes initiative and ownership of results; demonstrates a high-level of self-accountability.

Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently.

PC/Technical skills- MS Office, Excel, Word, PowerPoint

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

The potential base pay range for this role, when annualized, is $169,200.00 - $471,500.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled