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.
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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.
European Union Regulatory Affairs, Medical Device, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
This position will be responsible for global regulatory activities related to the development and implementation of global regulatory strategies to support the submission, filing, and registration of multiple indications (clinical applications or “apps”) in Dermatology and Oncology medical devices in targeted global markets. This role provides leadership in the strategic guidance and execution of regulatory concepts within cross-functional project teams and supports interactions with global health authorities and corporate partners with regulatory deliverables. In addition, this position will require direct and hands on experience to support the development and implementation of FDA QSR, EU MDR (EU 2017/745) and ISO 13485: 2016 QMS, and applicable international regulatory compliance activities.
Develop and implement competitive and effective global regulatory strategies for various Dermatology, General/Plastics and Oncology products including clinical/NSR and identify potential risks associated with proposed strategies
Manage all aspects of international regulatory affairs by driving the creation, assembly, compile, review and submission of technical documentation such as Technical Files, Design Dossiers including the General Safety and Performance Requirements (GSPRs) for product CE Marking and post-market follow-ups including amendments/supplements related to clinical trials under the new EU MDR (EU 2017/745)
Support FDA regulatory with the creation, review, editing, assembly and submission of domestic FDA regulatory documentation such as 510ks, Pre-subs, Letter-to-Files, IDEs, PMAs, etc. including regulatory responses and agency interactions
Oversees the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports
Interacts with regulatory agencies to expedite submissions and/or approval of pending registrations
Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
Assist Clinical operations and ensuring clinical study results and reports are suitable for regulatory submissions
Experience with Notified Body, Authorized Representative, Competent Authority and regulatory intelligence activities and clinical registration databases to support product approval strategies.
Responsible for adverse event (Vigilance, MDR) reporting and assessments of AE’s to determine “reportable” events. Provide regulatory support as required in the evaluation of product complaints and ensuring AE reports meet regulatory requirements.
Establish and maintain procedures relating to the MDR/CE Marking processes in accordance with MEDDEV, ISO, and applicable international and country-specific regulatory requirements.
Serves as regulatory liaison throughout product development lifecycle.
Participates in some of the followings: product plan development and implementation, regulatory strategy, product labeling, risk management, post-market surveillance and post-market follow-up
Ensure alignment of regulatory strategy to business strategy across all functional area including timely approval of new medical devices and continued expansion approvals of marketed products.
Serves as regulatory representative to marketing, clinical, research teams and regulatory agencies.
Accountable for ensuring that regulatory submissions, technical documentation meet appropriate standards, guidance, and content requirements.
Advises development and/or marketing teams on product changes, line extensions, technical labeling, appropriate regulations and interpretations
Write regulatory justifications to support design changes and submission filing decisions
Carry out responsibilities in accordance with the organization’s policies and applicable laws
Support the Pulse Biosciences Quality Policy and Quality System.
Adaptable team player with the ability to work cross-functionality.
Bachelor degree in a life sciences, engineering, or technical related discipline.
5 to 8 years of experience in Regulatory Affairs in the medical device or biotechnology industries, including an in-depth knowledge and understanding of the regulatory environment. Dermatology (aesthetics) and/or General/Plastics Surgery regulatory experience preferred.
Knowledge of current EU regulations, Notified Body conformity assessment including experience preparing, compiling, filing, and performing life-cycle management of applications and all Technical Documentation format.
Experience with health authority meeting preparation.
Proven ability to independently manage critical projects as part of an interdisciplinary team. In addition, the candidate should have hands-on experience preparing, managing and submitting major regulatory submissions.
Ability to successfully manage multiple projects and navigate challenges to deadlines.
Good communication skills in both verbal and non-verbal.
Have solid understanding and proving practices within both EU MDR 2017/745, ISO 13485: 2016 and FDA QSR regulations.
Experienced with both high risk device and non-significant risk device classes (Class III/IIb/IIa/II)
Familiar with both FDA Electrosurgical guidance and IEC 60601 Safety requirements.
Internal Number: N-419-400-01
About Pulse Biosciences
Pulse Biosciences is a bioelectric medicine company pursuing commercial introduction of our proprietary CellFX™ System utilizing our patented Nano-Pulse Stimulation™ (NPS™) technology. The unique cell-specific effects of the NPS mechanism of action have the potential to significantly benefit patients across multiple medical applications, including dermatology, our first planned commercial application.
To date, we own or have a license to more than 94 issued patents worldwide. With this growing patent portfolio surrounding our innovative technology, Pulse Biosciences seeks to aggressively realize the potential of Nano-Pulse Stimulation technology, building a rich pipeline of transformative commercial applications.
From the launch of our first planned commercial offering, the CellFX System, to our current ongoing clinical studies, to the planned studies that fuel our rich pipeline, we see a clear path to the future as Pulse Biosciences brings the promise of NPS technology from the lab to lives of real patients today, and tomorrow.