Principal Global Regulatory Affairs Specialist

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 procedures relating to the MDR/CE Marking processes in accordance with MDCG, ISO, and applicable international and country-specific regulatory requirements.
• Serve as regulatory liaison throughout product development lifecycle.
• Participate in some of the following: product plan development and implementation, regulatory strategy, product labeling, risk management, post-market surveillance and post-market follow-up.
• Ensure alignment of regulatory strategy to business strategy across all functional areas including timely approval of new medical devices and continued expansion approvals of marketed products.
• Serve as regulatory representative to marketing, clinical, research teams and regulatory agencies.
• Ensure regulatory submissions and technical documentation meet appropriate standards, guidance, and content requirements.
• Advise development and/or marketing teams on product changes, line extensions, technical labeling, appropriate regulations and interpretations.
• Write regulatory justifications to support design changes and submission filing decisions.
• Carry out responsibilities in accordance with the organization’s policies and applicable laws.
• Support the Pulse Biosciences Quality Policy and Quality System.

To Excel, You Will Bring:

• Bachelor’s degree in Engineering, technical related discipline, other life science related discipline or equivalent experience.
• 10+ years of experience in Global Regulatory Affairs in the medical device or biotechnology industries, including an in-depth knowledge and understanding of the regulatory environment or 8+ years of experience with a Master’s degree.
• Experience creating PMA submission and CE Marking under MDR required
• Regulatory experience in general/plastics surgery, cardiology, and/or dermatology (aesthetics) highly preferred.
• Experience with Notified Body, Authorized Representative, Competent Authority and regulatory intelligence activities and clinical registration databases to support product approval strategies.
• Knowledge of current EU regulations, Notified Body conformity assessment including experience preparing, compiling, filing, and performing life-cycle management of applications and all Technical Documentation format.
• Experience with health authority meeting preparation.
• Experience with Class III devices.
• Solid understanding of both EU MDR 2017/745, ISO 13485: 2016 and FDA QSMR regulations.
• Proven ability to independently manage critical projects as part of an interdisciplinary team and navigate challenges to deadlines.
• Hands-on experience preparing, managing and submitting major regulatory submissions.
• Excellent oral and written communication skills with 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.
• 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.

Pay Range:

Compensation is determined based on a wide range of factors including location, job-related skills, experience, education, and training. It is not typical for an individual to be hired at or near the top of the range for their role. This pay range is specific to Northern California location. Base salary range: $160k-$190k. This position is located onsite in Hayward, CA and candidates must reside in the San Francisco Bay Area. No relocation offered.