Regulatory Affairs Manager
This position will be responsible for all regulatory activities related to the development and implementation of both US (FDA) and OUS global regulatory strategies to support the submission, filing, and registration of multiple indications in Dermatology and Oncology medical device development assets. 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 support the development and implementation of FDA QSR and ISO 13485: 2016 QMS, EU MDR regulatory requirements, and applicable international regulatory compliance activities.
- Develop and implement competitive and effective domestic (US FDA) and global regulatory strategies for various Dermatology, General/Plastics, Immunology and Oncology products including clinical and nonclinical and identify potential risks associated with proposed strategies
- Manage and participate in the creation, review, assembly and submission of regulatory documentation such as 510ks, Pre-subs, IDEs, HDEs, PMAs, Early Feasibility Study (EFS), Early Access Program (EAP) or Breakthrough Device Designations (BDD), and its international equivalents such as Technical Files, Design Dossiers for CE Marking including amendments/supplements related to clinical trials
- Oversees the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports
- Interacts with regulatory agency to expedite approval of pending registration
- Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
- Serves as regulatory liaison throughout product lifecycle
- Participates in some of the following: product plan development and implementation, regulatory strategy, product labeling, risk management
- Ensures timely approval of new medical devices and continued approval of marketed products.
- Serves as regulatory representative to marketing, research teams and regulatory agencies.
- Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations
- Carry out responsibilities in accordance with the organization’s policies and applicable laws
- Support the Pulse Biosciences Quality Policy and Quality System.
- Bachelor degree in a life sciences, engineering, or related discipline.
- 8 to 10 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), General/Plastics Surgery, and Immuno-Oncology (I-O) regulatory experience preferred.
- Knowledge of current US and EU regulations, including experience preparing, filing, and performing life-cycle management of applications and all supportive amendments, supplements to the United States Food and Drug Administration (US-FDA) in e-submission document 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.
- Experience with regulatory intelligence activities and clinical registration databases to support product approval strategies.
- Good communication skills in both verbal and non-verbal.
- Have good understanding and proving practices within both FDA QSR and EU MDR//ISO 13485 regulations.
- Experienced with both high risk device and non-significant risk device classes (Class III/IIb/IIa/II)