Position Overview:

The Regulatory Affairs Manager will plan, track, and manage complex regulatory projects.  The role will be directly responsible for crafting thorough regulatory strategies and compose comprehensive regulatory submissions, ensuring adherence to applicable regulations and standards.  The role is expected to collaborate and build relationships with cross-functional teams, regulatory agencies, and external partners to drive successful project outcomes.  Additionally, the role will directly or indirectly lead cross-functional teams in the execution of end-to-end programs and project plans, including but not limited to assessing regulatory deliverable requirements, communicating effectively across the organization and advising teams on pathways to successful regulatory compliance.  The RA manager will also be responsible for independently providing strategic regulatory guidance and input on commercial (Ad/promo) and corporate communications, and play a critical role in ensuring that these activities uphold fair balance and are compliant with regulations and Outset’s policies and procedures.

Essential Job Functions and Responsibilities:

• Prepare and submit regulatory submissions to FDA with minimal supervision.
• Develop and implement regulatory strategies to ensure compliance with local and international regulations.
• Stay current with industry regulations and proactively communicate changes to relevant stakeholders.
• Conduct regulatory assessments and provide guidance on potential impact to projects.
• Lead and coordinate regulatory affairs projects from initiation to completion. Develop project plans, timelines, and milestones, ensuring alignment with organizational goals.
• Reviews and approves promotional material.
• Collaborate with cross-functional teams to achieve project objectives on time and within budget.
• Act as a liaison between internal teams and regulatory agencies to facilitate communication and information exchange.
• Participate and collaborate with external partners and trade agencies as required to ensure compliance with regulatory requirements.
• Create and maintain SOPs related to regulatory affairs.
• Conduct internal audits to ensure ongoing compliance with regulatory standards.
• Identify potential risks and develop strategies to mitigate regulatory compliance challenges.
• Provide guidance on risk assessment and management related to regulatory affairs.
• Communicate expeditiously and effectively on regulatory topics with senior leadership and drive closure to regulatory issues with a problem-solving mindset.
• Support additional activities, as assigned.

Required Qualifications: 

• Education requirements, including area of focus.
  • Bachelor's degree in Life Sciences, Engineering or equivalent.
• Work Experience
  • Minimum 10 years’ experience in in Regulatory Affairs within the Medical Device industry
  • Direct experience in authoring regulatory submissions end-to-end.
  • Proven track record in leading successful US FDA submissions, including pre-submissions, 510(k)s, IDEs, De Novo 510(k)s and other global product registrations as the primary point of contact.
  • Prior experience in reviewing and approving ad/promo material in compliance with FDA regulations.
• Skills or knowledge:
  • In-depth knowledge of relevant regulations and standards.
  • Proven experience in regulatory affairs, with a focus on project management.
  • Strong project management skills with the ability to manage multiple projects simultaneously.
  • Good communication and interpersonal skills.
  • Detail-oriented with a high level of accuracy.
  • Ability to work collaboratively in a cross-functional team environment.
  • Can operate independently and have excellent problem-solving skills.

Desired Qualifications:

• 10+ years of regulatory affairs experience in the medical device industry, with a track record of successful submissions.
• Well versed with software development standards such as IEC 62304 and FDA regulations around SAMD, SiMD and content pertaining to Cybersecurity, software, electrical, Artificial Intelligence and Machine Learning.
• Prior experience in Renal Therapies or hemodialysis industry is a plus.
• Certification in Regulatory Affairs (RAC) is a plus.
• Experience in software (SaMD) is strongly preferred.
• Ability to work on-site at San Jose HQ a minimum of 3 days per week.
• Flexibility to travel 10% of the time.