Regulatory Consultant, Medical Device, Home-Based Usa - Iqvia Medtech

IQVIA is seeking a Regulatory Consultant with strong Medical Device Regulatory Submissions experience.

JOB OVERVIEW
Manages multiple MedTech Regulatory consulting projects of varying complexity and ensures on-time and on-budget delivery for clients in MedTech or related industries. Serves as point person on engagements. Contributes to new business development and maintaining and strengthening client base. Primary responsibility is to research, draft, and create strategy for traditional regulatory submissions.

ESSENTIAL FUNCTIONS

• Serves as key point of contact with client.
• Develops and/or elevates new business opportunities through the identification of follow-on work and new leads.
• Maintain proficiency of skills and knowledge and remain current with industry trends based on current literature, regulatory guidance documents, application of new technology, attendance at professional meetings, etc.
• Ensures clear communication throughout projects and within the team.
• Manage project deliverables including regulatory strategy assessments, regulatory plans, progress reports, presentations, premarket submissions, communications with regulatory authorities. Adjust resources, deliverables and client expectations accordingly.
• Develops broader and deeper knowledge of consulting methodologies and MedTech market through on the job experience and training.
• Manages project teams/staff including both internal and external resources, when applicable, in the design, development and delivery of client deliverables.
• Shares subject matter expertise with others to elevate our capabilities to deliver world-class solutions for clients.
• Leads ad hoc work streams on critical people-related issues such as recruitment, learning and development.
• May manage the process of proposal preparation and/or modifications including overall bid integrity.
• May present relevant regulatory topics to industry clients and at professional conferences. Publish materials such as fact sheets, white papers.
• Provides direction, advice and intellectual leadership to clients and delivery teams.
• Directs consulting teams through consistent participation in team meetings.
• Provides follow-up with client after project deliverable has been completed to ensure client satisfaction.
• May serve as a coach to junior staff.
• Monitor project time charges within the functional group.
• Define and implement regulatory strategic plans in the applicable program areas
• Supports the development of intellectual property for use on future engagements.
• Leverages business experience and acumen in identifying strategic alternatives and project approach to client questions.
• Provides high level input to, and ensures the development of, client reports and presentations and delivery of all or significant portions of findings to client.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Project planning methodology, problem analysis, development and technical writing for marketing applications and communications with regulatory authorities
• Sound knowledge of regulatory processes and requirements for all medical device and diagnostics classifications
• Excellent verbal and written communication skills.
• Strong interpersonal and organizational skills.
• Sound knowledge and understanding of FDA and Health Canada submission processes
• Strong influencing and negotiation skills.
• Ability to lead, guide and motivate project team members to achieve desired results.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients

QUALIFICATIONS

• A willingness and ability to travel 10%
• 6+ years professional experience in consulting, MedTech and/or healthcare industry with evidence of career progression [Req]
• Master’s Degree/ MBA or Higher degree [Pref]
• A track record of leadership
• Demonstrable experience in and commitment to the life sciences and/or healthcare industries.
• Bachelor's Degree in life science related discipline or related field [Req]

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

New York City Pay Transparency : The salary range for this role is $154,600 - $193,800.The actual salary will vary based on factors like candidate qualifications and competencies.