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.