Principal/Sr. Regulatory Affairs Specialist
Pulse Biosciences (Nasdaq: PLSE) is a bio-electric medicine company committed to health innovation that has the potential to improve and extend the lives of patients. The CellFX® System will be the first commercial product to harness the distinctive advantages of our proprietary 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.
We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members. We take pride in hiring the best and brightest minds to our world-class company. Individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude will excel in our culture.
The Principal or Senior Regulatory Affairs Specialist will be responsible for regulatory activities related to the development and implementation of regulatory strategies to support the submission and filing of multiple indications in Dermatology, General/Plastics and Oncology for electrical surgical medical device products in the US. This role provides leadership within cross-functional project teams and execution of regulatory deliverables and submissions. 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 regulatory compliance activities.Essential Duties and Responsibilities:
- Develop and implement competitive and effective FDA regulatory strategies for various Dermatology, General/Plastics and Oncology products and identify potential risks associated with proposed strategies.
- Manage and participate in the creation, review, editing, assembly and submission of regulatory documentation such as 510(k)s, Pre-subs, Letter-to-Files, IDEs, and PMAs. Responsible for implementation and operations for regulatory submissions, progress reports, supplements, amendments, or periodic reports.
- Interacts with regulatory agencies to expedite submissions and/or approval of pending regulatory reviews.
- Monitors regulatory outcomes of initial product concepts and provide input to senior regulatory management.
- Reviews preclinical and clinical study documents and reports 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 or clearance 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 and 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.
- Writes regulatory justifications to support design changes and submission filing decisions.
- Carries out responsibilities in accordance with the organization’s policies and applicable laws.
- Support the Pulse Biosciences Quality Policy and Quality System.
- May perform other duties as assigned.
Education and Experience:
- Bachelor’s degree in a life sciences, engineering, or related discipline.
- 5 to 10 years of experience in Regulatory Affairs in the medical device industry including an in-depth knowledge and understanding of the FDA regulatory environment.
- Solid understanding and proving practices within both FDA QSR regulations and ISO 13485: 2016 quality system management.
- Experience with both high risk device and low risk medical devices (Class III/II/I).
- Experience with clinical and indication expansion submissions is a plus.
- Dermatology (aesthetics), General/Plastics Surgery or Oncology or electrical surgical devices experience preferred.
Skills, Abilities, and Other Requirements:
- Adaptable team player with the ability to work cross-functionality.
- Proven ability to independently manage critical projects as part of an interdisciplinary team. Hands-on experience preparing, managing and submitting major regulatory submissions.
- Ability to successfully manage multiple projects and navigate challenges to deadlines.
- Proficient knowledge and skill in Microsoft Office Suite applications.
- Excellent oral written communication skills and critical thinking skills.
- Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
- Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast-growing company.
- Ability to travel up to 10% of the time. Overnight and/or international travel may be required.
- Ability to lift 10-15 pounds.
Pulse Biosciences currently maintains a policy requiring all United States-based employees to be fully vaccinated against COVID-19. In accordance with applicable law, Pulse Biosciences will consider reasonable accommodations to employees who qualify as required under federal, state and local law where it is not an undue hardship to the company to do so.
Our corporate headquarters is located in Hayward, California. To learn more about us, visit our website at www.pulsebiosciences.com.
At Pulse Biosciences, we are committed to providing a respectful work environment to our diverse workforce. We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.
LOCAL CANDIDATES ONLY
Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.