Regulatory Affairs Specialist - Pleasanton, CA

Summary:

As a key member of the Regulatory Affairs team, you will play a vital role in ensuring compliance with global medical device regulations throughout the product lifecycle. You will oversee and execute post-market regulatory activities, including medical device reporting (MDR), regulatory submissions, and promotional material reviews. This role involves close collaboration with cross-functional teams such as Medical Affairs, Quality, and Risk Management to maintain regulatory compliance, support product changes, and respond to regulatory authorities. Your knowledge of domestic and international regulatory requirements will help guide internal stakeholders and contribute to continuous improvement across quality systems and compliance processes.

In This Role, You Will:

• Oversee and execute medical device reporting (MDRs) and post-market medical device compliance activities in accordance with applicable regulations and internal procedures.


• Partner with Medical Affairs and Quality to review complaints and ensure decision trees for reportability to regulatory agencies meet global regulatory expectations and support continuous improvement.


• Support other regulatory compliance activities such as review and approval of promotional materials, advertising claims, and customer-facing communications.


• Leads the compilation and submission of periodic regulatory compliance reports, annual registrations and listings for products in commercial distribution.


• Maintain visibility into evolving global regulatory requirements and proactively update internal stakeholders. Develop and manage domestic and international registration and listing activities, when assigned.


• Support risk management, and responses to regulatory agencies for field actions or advisory notices.


• Reviews proposed changes to product design, manufacturing processes and labeling for regulatory impact, when assigned.


• Provides regulatory support for post-market risk management activities


• Provides regulatory support and representation for teams engaged in changes to Quality System processes.


• Must be familiar with US and international regulatory requirements for medical devices (e.g., European medical device directives, international standards for medical devices, FDA regulations concerning devices, including the Quality System Regulation (QSR), Good Laboratory Practices (GLPs) and Good Clinical Practices (GCPs).


• Experience with electronic QMS systems such as Propel, Windchill, Arena etc. required.

Who You Will Report To:

• See Organizational Chart

Requirements:

• 5+ years of regulatory affairs experience in the medical device industry, including electromechanical medical devices, Class II or Class III medical devices.


• Proven success with communicating with regulatory agencies for regulatory compliance activities in a medical device company.


• Expertise in reviewing and approving product claims and promotional content in a fast-paced, innovative environment.


• Strong understanding of U.S. regulatory requirements; familiarity with EU MDR and other international regulations preferred.


• Effective communicator and relationship-builder with cross-functional stakeholders and external regulators.


• Excellent interpersonal skills; ability to work and contribute to a team environment


• Self-motivated and capable of working with supervision and guidance


• Demonstrated ability in analytical reasoning and critical thinking skills


• Ability to handle multiple tasks and meet deadlines


• Excellent organizational and communication skills; both oral and written


• Demonstrated ability to contribute to a continuous learning and process improvement environment


• Bachelor’s degree in Life Sciences, Biomedical/Bioengineering, or related field required; advanced degree and/or RAC certification preferred.


• Work Location: Pleasanton, CA // Hybrid


• Travel: 5% travel may be required


• Full-time employment


• Must be able to sit for up to 8 hours/day


• Compliance with relevant county, state, and Federal rules regarding vaccinations.

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer an attractive compensation package, which includes:

• A competitive base salary of $115,000 - $125,000 and variable incentive plan


• Stock options – ownership and a stake in growing a mission-driven company


• Employee benefits package that includes 401(k), healthcare insurance and paid vacation