The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
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Clinical Trials, European Union Regulatory Affairs, Quality/Risk Management, Submission & Registration
This position requires a strong candidate with experience in medical writing of clinical and regulatory documents. This individual will manage a team of Regulatory & Clinical Technical Writers to support US, Health Canada, MDD/MDR, and Rest of World requirements. This includes Clinical Evaluation Plans/Reports, Post-Approval Studies, and additional support with submission writing. The Regulatory & Clinical Technical Writing Manager contributes scientific knowledge and analytical skills to the preparation of clinical & regulatory documentation.
Lead and manage a team of Technical Writers and drive consistency in processes and project management to obtain CE-mark (re)certification, support post-approval studies, and further development of products.
Ensure timely delivery of Clinical Evaluation Reports and other EU MDR-associated deliverables (PMCF Plan, SSCP, PMSR, etc.) as well as FDA and Rest of World Regulatory/Clinical needs
Proactively identify MDR gaps and innovate to address these with stakeholder alignment.
Cultivate strong relationships with key cross-functional team members and stakeholders to align on timing of deliverables, clinical strategies and subject matter expertise input.
Represent Regulatory & Clinical Writing team in project teams across departments.
Lead program execution to enable results and maintain commitments, including escalation to management for resolution of non-standard solutions.
Partner with other program leaders to ensure coordination of activities and timelines with an eye to efficiently use resources and effectively drive change.
Develop recommendations and prepare executive-level presentations for Key Stakeholders.
Responsible for management of issues associated with program interdependence, resource allocation and financial management; partner with change and communication leadership on communications and organizational change management issues.
Partner with Subject Matter Expert(s) regarding common interpretation and guidance, deliverables, pace and progress across the organization to ensure a harmonized approach for achieving compliance.
Previous experience in the application of in-depth therapeutic and/or device knowledge to development of clinical evaluation plans/reports.
Ability to identify critical information needs and identify roles / individuals to involve for decision making within clinical evaluation assessment and report development.
Strong experience in conducting literature searches, reviews and appraisal of the scientific data.
Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing; demonstrated effective scientific writing skills.
Solid critical and analytical thinking skills.
High attention to detail and accuracy; ability to work independently; accountable for outcomes.
Proven ability to develop trusted relationship and collaborate with co-workers and functional partners in a matrixed organization.
Strong communication, presentation and interpersonal skills with high attention to detail and organization.
Strong experience in protocol development, writing clinical section for regulatory submission and clinical evaluation report writing.
Ability to learn quickly and self-educate on different surgical specialties as applicable to medical products and procedures (Self-starter attitude).
Consistently shows dedication or strong work-ethic to help meet aggressive timelines or multiple projects when necessary.
Required/ Preferred Education and Experience:
Masters, PhD, MD, or Doctoral degree with preference towards healthcare, medical, or scientific profession (e.g., nursing, medicine, epidemiology, pharmacology, biological science or other related medical/scientific field).
Clinical Research and/or medical writing (CER) experience within a medical device industry.
Management experience (managerial, people management). Direct experience as a manager or supervisor leading and managing a team of professionals, and experience hiring, coaching and development team members.
Advanced ability to understand and apply practical medical/scientific and product knowledge in a competent and consistent manner.
Internal Number: JC349
About ZOLL Medical Corporation
ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success.
We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL!