Principal Global Regulatory Affairs Specialist

Pulse Biosciences•Hayward, CA

22h•$160,000 - $190,000•Onsite

About The Position

The Principal Global Regulatory Affairs Specialist leads regulatory activities and develops and implements global regulatory strategies supporting submissions, filings, and registrations for multiple indications in general surgery, cardiac surgery, and dermatology medical devices in targeted global markets. The role provides strategic regulatory guidance and execution within cross-functional project teams, supports interactions with global health authorities and corporate partners, and brings hands-on experience with FDA QSR, EU MDR (EU 2017/745), ISO 13485:2016, and applicable international regulatory compliance activities. The position oversees international and domestic regulatory documentation and submissions, regulatory agency interactions, product registration strategies, and regulatory support across the product development lifecycle. It also contributes to clinical, labeling, risk-management, and post-market activities; supports vigilance and adverse-event reporting; and ensures regulatory strategies and documentation align with business goals, applicable standards, and regulatory requirements. This position is onsite in Hayward, California. Candidates must reside in the San Francisco Bay Area. The role may require up to 10% travel, including overnight or international travel. The listed Northern California base salary range is $160,000–$190,000. No relocation is offered.

Requirements

Bachelor’s degree in engineering, a technical-related discipline, another life-science-related discipline, or equivalent experience.
At least 10 years of global regulatory affairs experience in medical devices or biotechnology, including in-depth knowledge and understanding of the regulatory environment; alternatively, at least 8 years of experience with a master’s degree.
Experience creating PMA submissions and obtaining CE Marking under MDR.
Experience with Notified Bodies, Authorized Representatives, Competent Authorities, regulatory intelligence activities, and clinical registration databases to support product approval strategies.
Knowledge of current EU regulations and Notified Body conformity assessment, including preparing, compiling, filing, and lifecycle-managing applications and technical documentation.
Experience preparing for health authority meetings.
Experience with Class III devices.
Solid understanding of EU MDR 2017/745, ISO 13485:2016, and FDA QSMR regulations.
Demonstrated ability to independently manage critical projects within interdisciplinary teams and navigate challenges to meet deadlines.
Hands-on experience preparing, managing, and submitting major regulatory submissions.
Excellent oral and written communication and critical-thinking skills.
Ability to work conscientiously with minimal direction, exercise good judgment and initiative, manage short- and long-range projects, and recommend actions.
Ability to work as a team member, multitask, and adapt flexibly to changing priorities and requirements in a dynamic, fast-growing company.
Proficient knowledge and skill in Microsoft Office Suite applications.
Ability to travel up to 10% of the time; overnight and/or international travel may be required.
Ability to lift 10–15 pounds.
Must reside in the San Francisco Bay Area.

Nice To Haves

Regulatory experience in general or plastic surgery, cardiology, and/or dermatology (aesthetics) is highly preferred.

Responsibilities

Implement competitive and effective global regulatory strategies for general surgery, cardiac surgery, and dermatology products, including clinical and NSR products, and identify potential risks associated with proposed strategies.
Manage international regulatory affairs from creation through submission of technical documentation, including Technical Files, Design Dossiers, GSPRs for CE Marking, post-market follow-ups, and clinical-trial amendments or supplements under EU MDR.
Support FDA regulatory activities by creating, reviewing, editing, assembling, and submitting documentation such as 510(k)s, Pre-Subs, Letter-to-Files, IDEs, and PMAs, including regulatory responses and agency interactions.
Oversee strategy implementation and operations for product registration submissions, progress reports, supplements, amendments, and periodic experience reports.
Interact with regulatory agencies to expedite submissions 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.
Assess adverse events for reportability and manage Vigilance and MDR reporting; support product complaint evaluations and ensure adverse-event reports meet regulatory requirements.
Establish and maintain procedures for MDR and CE Marking processes in accordance with MDCG, ISO, and applicable international and country-specific requirements.
Serve as regulatory liaison throughout the product development lifecycle.
Participate in product-plan development and implementation, regulatory strategy, product labeling, risk management, post-market surveillance, and post-market follow-up.
Align regulatory strategy with business strategy across functions, supporting timely approvals of new devices and expansion approvals for marketed products.
Represent regulatory affairs to marketing, clinical, and research teams and regulatory agencies.
Ensure regulatory submissions and technical documentation meet applicable standards, guidance, and content requirements.
Advise development and marketing teams on product changes, line extensions, technical labeling, and relevant regulations and interpretations.
Write regulatory justifications supporting design changes and submission-filing decisions.
Carry out responsibilities in accordance with organizational policies and applicable laws.
Support the Pulse Biosciences Quality Policy and Quality System.