Principal Global Regulatory Affairs Specialist

Pulse Biosciences•Hayward, CA

21d•Onsite

About The Position

The Principal Global Regulatory Affairs Specialist leads regulatory activities and develops and implements global regulatory strategies to support 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 and supports interactions with global health authorities and corporate partners. It requires hands-on experience supporting FDA QSR, EU MDR (EU 2017/745), ISO 13485:2016, and applicable international regulatory compliance activities. The specialist manages international regulatory affairs from preparation through submission of technical documentation, including Technical Files and Design Dossiers with General Safety and Performance Requirements for CE Marking, post-market follow-up, and clinical-trial amendments or supplements under EU MDR. The role also supports domestic FDA submissions and agency interactions; oversees product-registration submission strategies and operations; contributes regulatory input across the product lifecycle; and supports adverse-event reporting, product complaints, and MDR/CE Marking procedures. This is an onsite position in Hayward, California. Candidates must reside in the San Francisco Bay Area; relocation is not offered. Travel of up to 10% may be required, including overnight or international travel. The stated Northern California base salary range is $160,000–$190,000.

Requirements

Bachelor’s degree in engineering, a technical discipline, a life-science discipline, or equivalent experience.
At least 10 years of global regulatory affairs experience in the medical-device or biotechnology industries, including in-depth knowledge 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, and clinical registration databases to support product-approval strategies.
Knowledge of current EU regulations and Notified Body conformity assessment, including preparation, compilation, filing, and lifecycle management of 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 meet deadlines while navigating challenges.
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, complete short- and long-range projects, and recommend actions.
Ability to work as a team member, multitask, and adapt flexibly to changing priorities in a dynamic, fast-growing company.
Proficiency with 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 for this onsite Hayward, California position; relocation is not offered.

Nice To Haves

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

Responsibilities

Implement effective global regulatory strategies for general surgery, cardiac surgery, and dermatology products, including clinical and NSR applications, and identify risks associated with proposed strategies.
Manage international regulatory affairs activities, including creation and submission of Technical Files and 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-submissions, 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 pending registration approvals.
Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management.
Collaborate with clinical operations to ensure study results and reports are suitable for regulatory submissions.
Manage adverse-event (Vigilance and MDR) reporting and assess events for reportability; 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 the regulatory liaison throughout the product development lifecycle and contribute to product planning, regulatory strategy, labeling, risk management, post-market surveillance, and post-market follow-up.
Align regulatory strategy with business strategy across functions to support timely device approvals and expansion approvals for marketed products.
Represent regulatory affairs to marketing, clinical, 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 applicable regulations and interpretations.
Write regulatory justifications supporting design changes and submission-filing decisions.
Carry out responsibilities in accordance with organizational policies and applicable laws, and support the Quality Policy and Quality System.