IQVIA

Director, Regulatory Affairs - Neurology MedTech

IQVIA • $135K — $376K *
Washington, DC 20011In-Person
Healthcare
8 - 10 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred
  • 10+ years of regulatory experience in medical device development, especially in neurology
  • Project management and managerial experience required
  • Fluency with US and/or International regulations (e.g., FDA, ISO 13485)
  • Strong technical writing and communication skills

Responsibilities

  • Develop and execute regulatory services, including regulatory submissions and strategies
  • Manage regulatory affairs staff and facilitate their professional development
  • Lead business development efforts to secure new clients
  • Create project budgets and timelines as necessary
  • Collaborate with cross-department teams to enhance regulatory practices

Benefits

  • Mentorship and training opportunities for career growth
  • Collaboration with diverse teams in a multidisciplinary environment
  • Exposure to a wide scope of regulatory services
  • Opportunity to influence and shape departmental direction
Full Job Description
Overview
The Director, Regulatory Affairs - Neurology MedTech will be a critical team member supporting regulatory strategy and submissions for the firm's clientele. The primary roles and responsibilities include managing the development of regulatory submissions, development of overall regulatory strategy, communicating with regulatory bodies and clients, and leading or expanding new therapy ideas, as applicable. The projects may be for companies in MCRA therapeutic areas, other MCRA areas of regulatory and scientific expertise, and/or other growing therapeutic concentrations of MCRA. The Director will also manage various personnel during various projects, as well as act as a mentor and trainer for junior employees.

Responsibilities and Duties
  • Develop and execute regulatory services for client companies, including however not limited to:
  • Regulatory Submissions (e.g., 510(k), IDE, PMA, IND, BLA, & IND, Technical Documentation, STED, CERs)
  • Regulatory Strategy, Analysis & Development
  • Design, Review & Implement Pre-Clinical Testing
  • Manage Regulatory Affairs staff, facilitate professional development and ensure regulatory projects are completed in an accurate and timely manner.
  • Lead/manage business development functions to secure new clients and projects.
  • Develop project and departmental budgets and timelines, as required.
  • Work directly with client companies and/or regulatory bodies without oversight.
  • Provide project leadership while maintaining sole relationship with client companies.
  • Lead people development projects, working alongside team managers, as required.
  • Work collaboratively with other MCRA departments, including clinical, RHEMA, and quality assurance.
  • Work with other department heads and executive management to guide progress and development of the regulatory department and company, as required.

Required Knowledge, Skills, and Experience
  • Education: Bachelor's degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred.
  • Certification/Licensure: Not applicable.
  • Experience: Neurology medical device experience required. Minimum ten 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 and/or managerial experience.

Other:
  • An understanding of clinical research and data analysis is required.
  • Possesses US and/or International 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.
  • Understanding of your team's regulatory landscape, including the breadth of services, how they interact, and how data flows between deliverables.
  • 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.
  • Able to creatively think through potential solutions and put the solution skillfully on paper.
  • Strong research, analytical, critical-thinking and problem-solving skills.
  • Strong professionalism with customer relations and managing client relationships.


The potential base pay range for this role, when annualized, is $135,300.00 - $376,800.00. 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.

About IQVIA

Innovex offers superior and creative advice to corporations. In addition, they raised venture capital for our own affiliate companies, in addition to having assisted clients in fund-raising efforts, new venture outreaches, and financing. Their engineers and technical staff offer varied backgrounds in manufacturing, high tech, product design, quality control, safety, biomechanics, and robotics.

IQVIA Careers

Join the vibrant team at IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services to the healthcare industry. IQVIA is recognized for its commitment to innovation, leadership in healthcare, and a culture that celebrates diversity and inclusion.

Work You’ll Do

At IQVIA, we offer job opportunities that empower you to leverage your skills and drive healthcare forward. Become part of a team that thrives on innovation and the pursuit of operational excellence, helping to improve patient outcomes across the globe.

Transform Your Career

IQVIA is the place where you can transform the world of healthcare while advancing your career. With a variety of positions available, from research and development to business analytics, IQVIA is at the forefront of the industry. Our leadership is committed to fostering a culture of growth and professional development, making IQVIA a prime environment for both seasoned professionals and those seeking an internship to kickstart their career.

Innovative Work Environment

Join over 50,000 dedicated professionals in a dynamic environment where technology meets healthcare. At IQVIA, innovation isn’t just a buzzword; it's the backbone of how we solve complex challenges. With cutting-edge resources and a collaborative global team, your work at IQVIA directly contributes to advancements in life sciences.

Career Development and Benefits

IQVIA believes in nurturing its team members not just as employees but as individuals seeking to grow their careers. We support this with unmatched benefits, diversity training, and opportunities for leadership development. Our commitment to your career growth is matched by our dedication to providing a supportive and inclusive workplace.

Explore Job Opportunities

Whether you’re looking for a full-time position, part-time work, or a graduate internship, IQVIA offers a range of employment options to match your career ambitions. Our hiring process is designed to be transparent and engaging, helping you to understand where your skills can best be utilized within the company.

Networking and Professional Development

At IQVIA, networking and professional development are part of our DNA. Engage with industry leaders, participate in global conferences, and take advantage of our in-house training programs designed to enhance your skills and advance your career.

Stay Connected

Join Our Team Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players. Explore the diverse job opportunities at IQVIA and find where you can make an impact.

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Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await at IQVIA. Embark on a journey of growth, innovation, and leadership at IQVIA. Shape your future in an environment that values diversity and fosters professional development. Join IQVIA today and transform healthcare through the power of information and technology.
Learn more about IQVIA
Size
82,000 employees
Market Cap
$37.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$279 million
Founded
2016
5 Year Trend
+15.3%
Revenue
$11.3 billion
NASDAQ
IQV
* Ladders Estimates

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