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.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Clinical Trials, European Union Regulatory Affairs, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
This position requires a strong candidate with experience in medical writing of clinical and regulatory documents. The position will mainly focus on development of Clinical Evaluation Plans/Reports (CERs), with future additional responsibility for development of other clinical evidence documents as part of the Medical Device Regulation and Medical Device Directive.
Authoring Clinical documentation mainly the Clinical Evaluation Plans and Reports (CEP/CER) including clinical section of regulatory authority requests.
Acquire or possess in-depth knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes and the ability to keep abreast of current literature.
Participates in and/or performs comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies, stay informed about applicable clinical landscapes and trends.
Providing product guidance and expertise to conduct literature searches on products/product families.
Review the literature and interpret and summarize risks, alternate therapies and device specific benefits from literature; collect and summarize primary data to support risk assessment.
Critically appraise scientific literature and write clinical summaries for products
Managing regulatory/clinical documentation timelines required by product development teams and global Regulatory Bodies by utilizing the appropriate project management tools.
Will support broader Clinical/Scientific Affairs activities such as Regulatory submissions/responses
Interacting with internal teams (engineering/product development/regulatory) to define the plan and strategy for development of the Clinical evaluation plans/reports for new products requiring CE Mark.
Perform periodic reviews of risk documentation and product labeling; ensure appropriate updates are implemented.
Provide clinical perspective and support to guide new product development for CE Mark purposes. May require ongoing core team support (e.g., weekly meetings) or periodic, as needed participation and input.
May author routine Clinical Study Progress Reports.
Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines)
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.
Excellent critical and analytical thinking skills.
Must have high level of attention to detail and accuracy.
Must be able to work effectively on cross-functional teams.
Must be able to manage multiple projects across numerous surgical disciplines.
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:
Must have a minimum of 2-5 years of medical writing experience
Minimum of 2 years of experience in clinical evaluation report writing in a medical device industry is preferred.
Bachelor’s degree in scientific, clinical or regulatory field is desired or equivalent work experience.
Internal Number: JC26
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!