Principal Regulatory Specialist
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.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- 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.
EDUCATION and EXPERIENCE:
- 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.