Manager, Regulatory Affairs

Location
Hayward, CA, United States
Posted
Feb 10, 2021
Ref
1021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Pulse Biosciences (Nasdaq: PLSE) is a bio-electric medicine company committed to health innovation that has the potential to improve and extend the lives of patients. The CellFX® System will be the first commercial product to harness the distinctive advantages of our proprietary Nano-Pulse Stimulation™ (NPS™) technology. The unique cell-specific effects of the NPS mechanism of action have the potential to significantly benefit patients across multiple medical applications, including dermatology, our first planned commercial application.

We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members. We take pride in hiring the best and brightest minds to our world-class company. Individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude will excel in our culture.

Position Summary:

The Regulatory Affairs Manager will be responsible for managing international (EMEA and APAC) regulatory activities related to the development and implementation of EMEA and APAC strategies to support the submission, filing, and registration of multiple indications (clinical applications or “apps”) in Dermatology and Oncology medical devices in targeted EMEA and APAC markets outside the US. This role provides leadership in the strategic guidance and execution of regulatory concepts within cross-functional project teams and supports interactions with EMEA and APAC health authorities and corporate partners with regulatory deliverables. In addition, s/he will require direct and hands-on experience to support the development and implementation of FDA QSR, EU MDR (EU 2017/745) and ISO 13485: 2016 under MDSAP QMS, and applicable international regulatory compliance activities.

Essential Duties and Responsibilities:
  • Develop and implement competitive and effective EMEA and APAC regulatory strategies for various Dermatology, General/Plastics and Oncology products including clinical/NSR and identify potential risks associated with proposed strategies.
  • Manage all aspects of EMEA and APAC regulatory affairs by driving the creation, assembly, compile, review, and submission of technical documentation such as Technical Files, Design Dossiers including the General Safety and Performance Requirements (GSPRs) to obtain product approvals, licensing, and registrations and post-market follow-ups including amendments/supplements related to clinical trials under applicable country-specific regulations.
  • Support both internal change assessments and external regulatory change notifications including regulatory responses and agency interactions.
  • Oversees the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
  • Interacts 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.
  • Manage, mentor, and train assigned team to be value-added and supportive of the EMEA and APAC goals and performance.
  • Assist Clinical operations and ensuring clinical study results and reports are suitable for regulatory submissions.
  • Responsible for adverse event (Vigilance) and field correction (Advisory Notice) 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 EMEA and APAC regulatory processes in accordance with MEDDEV, ISO, and applicable international and country-specific regulatory requirements.
  • Serves as EMEA and APAC regulatory liaison throughout product development lifecycle.
  • Participates in some of the followings: 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 area including timely approval of new medical devices and continued expansion approvals of marketed products.
  • Serves as regulatory representative to marketing, clinical, research teams and regulatory agencies.
  • Accountable for ensuring that regulatory submissions, technical documentation meet appropriate standards, guidance, and content requirements.
  • Advises 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 Management System.
Education and Experience:

  • Bachelor’s degree in a life sciences, engineering, or technical related discipline.
  • 8 to 10 years of experience in Regulatory Affairs in the medical device industry including an in-depth knowledge and understanding of the EMEA and APAC regulatory environments.
  • Dermatology (aesthetics) and/or General/Plastics Surgery, Oncology, Cardiology regulatory experience preferred.
  • Experience with national Health Authorities, Notified Body, Authorized Representative, Competent Authority and local regulatory intelligence activities and clinical registration databases to support product approval and commercial strategies.
  • Experience with both high risk device and non-significant risk device classes (Class IV/III/IIb/IIa/II).


Skills, Abilities, and Other Requirements:
  • Knowledge of current EMEA and APAC regulations, Notified Body conformity assessment including experience preparing, compiling, filing, and performing life-cycle management of applications and all Technical Documentation formats (STED).
  • Experience with health authority meeting preparation, interaction, responses, and issue resolving.
  • Solid understanding and proving practices within both EU MDR 2017/745, ISO 13485: 2016 and FDA QSR regulations.
  • Familiar with both FDA Electrosurgical Guidance and IEC 60601 Electrical Safety and EMC requirements.
  • Proficient knowledge and skill in Microsoft Office Suite applications.
  • Proven ability to independently manage critical projects as part of an interdisciplinary team. In addition, the candidate should have hands-on experience preparing, managing and submitting major regulatory submissions.
  • Ability to use online tools such as SmartSheet, MS Teams, Zoom to manage multiple and simultaneous projects and navigate challenges to deadlines.
  • Excellent oral written communication skills and 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.
  • Ability to travel up to 25% of the time. Overnight and/or international travel may be required.


Our corporate headquarters is located in Hayward, California. To learn more about us, visit our website at www.pulsebiosciences.com.

At Pulse Biosciences, we are committed to providing a respectful work environment to our diverse workforce. We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.

Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.