Principal Global Regulatory Affairs Specialist

pulsebiosciences; Hayward (CA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Stock options

401k plan

Health insurance

Paid time off

Annual bonus potential

Job summary

Pulse Biosciences is seeking a Principal Global Regulatory Affairs Specialist to lead regulatory strategy for general and cardiac surgery, as well as dermatology devices, across global markets. You will guide cross-functional teams through FDA QSR, EU MDR, and ISO 13485 programs, ensuring timely and compliant submissions.

You will manage international filings, coordinate with health authorities, and drive lifecycle management, including vigilance and post-market activities, enabling rapid, safe

Qualifications

• Lead global regulatory strategies for general surgery, cardiac surgery, and dermatology devices.
• Experience with FDA QSR, EU MDR, and ISO 13485 QMS; ensure regulatory compliance.
• Manage international regulatory submissions and interactions with health authorities.
• Collaborate with cross-functional teams to align regulatory plans with product development.

Responsibilities

• Develop and implement global regulatory strategies for multiple indications.
• Prepare and submit technical documentation (510(k), PMA, etc.) and regulatory filings.
• Coordinate regulatory interactions with FDA, EU authorities, and other agencies.
• Oversee post-market regulatory activities and vigilance reporting as needed.
• Support product registration, lifecycle management, and change controls.

Skills

Regulatory affairs

FDA submissions

EU MDR compliance

ISO 13485

CE Marking

Job description

Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine

Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. The Company's proprietary CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.

The Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit pulsebiosciences.com to learn more.

Why Join Us?

At Pulse Biosciences, we are driven by purpose and innovation.

Our Mission:

To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients. To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards. We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.

Our Culture:

A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration.

Our Commitment:

Hiring the best and brightest minds to advance our world-class organization.

What You Will Experience:

• Culture and Purpose - Purposeful and rewarding work collaborating with bright and curious minds brings us together!
• Innovative Environment - An environment that fosters innovation to take products from concept to human use quickly!
• Growth Opportunities - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!
• Comprehensive Benefits - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.
• Ownership and Rewards - Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.
• Work-Life Balance - Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.
• Diversity & Inclusion - A commitment to providing a respectful work environment to our diverse workforce.

About the Role

The Principal Global Regulatory Affairs Specialist will be responsible for 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 general surgery, and cardiac surgery and dermatology medical devices in targeted global markets. She/he 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. She/he brings direct and hands on experience supporting the development and implementation of FDA QSR, EU MDR (EU 2017/745) and ISO 13485: 2016 QMS, and applicable international regulatory compliance activities.

To Make an Impact, You Will:

• Implement competitive and effective global regulatory strategies for various general surgery, cardiac surgery, and dermatology products including clinical/NSR and identify potential risks associated with proposed strategies.
• Manage and drive all aspects of international regulatory affairs from creation to 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, 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.
• Oversee the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
• Interact 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.
• Collaborate with clinical operations to ensure clinical study results and reports are suitable for regulatory submissions.
• 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