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European Union Regulatory Affairs, Medical Device, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
This position will be responsible for regulatory activities related to the development and implementation of regulatory strategies to support the submission and filing of multiple indications (clinical applications or “apps”) in Dermatology and Oncology medical device products in targeted markets. This role provides leadership in the strategic guidance and execution of regulatory concepts within cross-functional project teams and supports interactions with FDA 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 and ISO 13485: 2016 QMS, and applicable international regulatory compliance activities.Under the direction of Associate Research Scientist, conduct in vitro and in vivo pre-clinical research to optimize the stimulation of the immune system using the Nano-Pulse Stimulation Platform. Conduct additional pre-clinical research where the data indicates further research.
Develop and implement competitive and effective FDA regulatory strategies for various Dermatology, General/Plastics and Oncology products including clinical/NSR and identify potential risks associated with proposed strategies
Manage and participate in the creation, review, editing, assembly and submission of regulatory documentation such as 510ks, Pre-subs, SIRs, Letter-to-Files, IDEs, and PMAs,) 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 regulatory reviews
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
Serves as regulatory liaison throughout product development lifecycle
Participates in some of the followings: product plan development and implementation, regulatory strategy, product labeling, promotional review, risk assessment, adverse events (eMDR), field action, etc.
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 related discipline.
5 to 10 years of experience in Regulatory Affairs in the medical device including an in-depth knowledge and understanding of the FDA regulatory environment. Dermatology (aesthetics) and General/Plastics Surgery, regulatory experience preferred.
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 FDA QSR regulations and ISO 13485: 2016 quality system management
Experienced with both high risk device and non-significant risk device classes (Class III/IIb/IIa/II)
Internal Number: R-319-400-01
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.