Lead Global Regulatory Affairs Expert

1 week ago

Hayward, California, United States Pulse Biosciences Full time
Job Overview

Pulse Biosciences is a pioneering bioelectric medicine firm dedicated to advancing health innovations that can significantly enhance patient quality of life. Our proprietary CellFX nsPFATM technology utilizes nanosecond pulses of electrical energy to non-thermally eliminate cells while preserving surrounding noncellular tissue. We are actively developing our CellFX nsPFA technology for applications in treating atrial fibrillation and other select markets where it can profoundly impact healthcare for patients and providers alike.

Our Commitment at Pulse:

  • We strive to positively influence the lives of patients, healthcare providers, shareholders, and our dedicated team members.
  • We take pride in attracting top-tier talent to our esteemed organization.
  • We value creativity, forward-thinking, and innovative problem-solving within our team culture.

Position Summary

As the Lead Global Regulatory Affairs Expert, you will oversee regulatory initiatives pertaining to the formulation and execution of global regulatory strategies aimed at supporting the submission, filing, and registration of various indications in general surgery, cardiac surgery, and dermatology medical devices across targeted international markets. You will provide strategic leadership and execution of regulatory concepts within cross-functional project teams while facilitating interactions with global health authorities and corporate partners concerning regulatory deliverables.

Your Impact Will Include:

  • Developing and implementing effective global regulatory strategies for diverse general surgery, cardiac surgery, and dermatology products, including clinical/non-significant risk assessments, while identifying potential risks associated with proposed strategies.
  • Managing all facets of international regulatory affairs from the creation to submission of technical documentation, including Technical Files and Design Dossiers, ensuring compliance with General Safety and Performance Requirements (GSPRs) for product CE Marking and conducting post-market follow-ups.
  • Supporting FDA regulatory processes through the creation, review, editing, assembly, and submission of domestic FDA regulatory documentation such as 510(k)s, Pre-subs, IDEs, PMAs, and other regulatory responses.
  • Overseeing the implementation of strategies for product registration submissions, progress reports, and amendments.
  • Engaging with regulatory agencies to expedite submissions and approvals of pending registrations.
  • Monitoring regulatory outcomes of initial product concepts and providing insights to senior regulatory management.
  • Collaborating with clinical operations to ensure clinical study results and reports are suitable for regulatory submissions.
  • Managing adverse event reporting and assessments to determine reportable events, providing regulatory support in evaluating product complaints to ensure compliance with regulatory requirements.
  • Establishing and maintaining procedures related to MDR/CE Marking processes in accordance with applicable international and country-specific regulatory standards.
  • Acting as the regulatory liaison throughout the product development lifecycle.
  • Participating in product plan development, regulatory strategy formulation, product labeling, risk management, and post-market surveillance.
  • Ensuring alignment of regulatory strategies with business objectives across all functional areas, facilitating timely approvals of new medical devices and continued expansion of marketed products.
  • Serving as a regulatory representative to marketing, clinical, and research teams as well as regulatory agencies.
  • Ensuring that regulatory submissions and technical documentation meet established standards and content requirements.
  • Advising development and marketing teams on product modifications, line extensions, technical labeling, and relevant regulations.
  • Documenting regulatory justifications to support design changes and submission decisions.
  • Performing additional duties as assigned.

Qualifications for Success:

  • Bachelor's degree in engineering, a technical discipline, or a life sciences-related field, or equivalent experience.
  • 5+ years of experience in Global Regulatory Affairs within the medical device or biotechnology sectors, with a comprehensive understanding of the regulatory landscape.
  • Regulatory experience in general/plastics surgery, cardiology, and/or dermatology is highly preferred.
  • Familiarity with Notified Body, Authorized Representative, Competent Authority, and regulatory intelligence activities, as well as clinical registration databases to support product approval strategies.
  • Knowledge of current EU regulations and Notified Body conformity assessments, including experience in preparing and managing technical documentation.
  • Experience in preparing for health authority meetings.
  • Experience with high-risk and non-significant risk devices across various classes.
  • Strong understanding of EU MDR 2017/745, ISO 13485:2016, and FDA QSR regulations.
  • Proven ability to independently manage critical projects within interdisciplinary teams and navigate challenges to meet deadlines.
  • Hands-on experience in preparing and submitting major regulatory submissions.
  • Excellent communication skills, both oral and written, along with strong critical thinking abilities.
  • Ability to work independently with minimal supervision, demonstrating good judgment and initiative in accomplishing projects.
  • Ability to function as a team member, multitask, and adapt to the dynamic priorities of a fast-growing organization.
  • Proficient in Microsoft Office Suite applications.
  • Willingness to travel up to 10% of the time, including potential overnight and international travel.
  • Ability to lift 10-15 pounds.

What You Will Experience:

  • Meaningful and rewarding work alongside talented and inquisitive colleagues.
  • A culture of learning focused on professional and personal growth that is characteristic of a startup environment.
  • A variety of health insurance plans and supplemental insurance options.
  • 401k retirement savings plan.
  • Stock options and Employee Stock Purchase Plan (ESPP) opportunities.
  • Paid time off, holidays, and a flexible work schedule.
  • A wellness program featuring free onsite gym access, mindfulness classes, and activities.
  • A commitment to fostering a respectful work environment for our diverse workforce.

Compensation:

Compensation is determined based on a variety of factors, including job-related skills, experience, education, and training. The base salary range is competitive and reflective of the Northern California market.

We are an equal opportunity employer, providing employment opportunities to all individuals regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by law. We will make reasonable accommodations for qualified individuals with disabilities.

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