Regulatory Affairs Specialist

Selflessness. Candor. Innovation. Execution. Objectivity. Excellence. Learning. Ownership. Clarity. Our core values make us who we are.

They’re the heart behind our success and why we continue to climb to the top—breaking barriers and transcending limits in our quest to change lives through laser.

Our passion for what we do motivates us to create life-changing innovations for our customers and their patients. You see, Sciton was founded by scientists who dreamt of improving the human condition through technology.

And that’s exactly what they did and what we continue to do at Sciton today.

We know our company’s strength stems from our diverse and talented people, and we’re committed to hiring others with the same innovative, team-oriented, and go-getter spirit.

Think you might be a good fit? Apply today.

Regulatory Affairs Specialist
Salary Range: $100 – $140k

We are hiring a Regulatory Affairs Specialist to join our team in Palo Alto, CA. In this role, you will provide regulatory guidance to cross-functional partners supporting various programs. You will prepare and submit for regulatory approvals and identify submission problems.

You will play a consultative role by partnering across business functions, identifying data needed, obtaining required documentation, and ensuring that submissions are effectively presented for the registration of products worldwide. 

In this role, you will:

• Represent RA on cross-functional product development and manufacturing support teams. Guide teams to provide content for international submissions and participate in design reviews.
• Conduct reviews of product and manufacturing changes for compliance with applicable regulations.
• Develop worldwide regulatory strategies for regulatory approval of company products or changes to commercial products.
• Prepare robust regulatory applications to achieve departmental and organizational objectives.
• Coordinate, compile, and submit international regulatory submissions, including filing and creating Dossiers, Premarket Notifications, Supplements, Change Notifications, and other country-specific product registrations.
• Interface directly with regulatory agencies as needed.
• Support the product release process by creating GTS licenses or reviewing and approving requests for product release.
• Support Department and Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
• Comply with international regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.

Essential Requirements: 

• Bachelor’s degree
• 3+ years of related experience in the medical device, pharmaceutical, or healthcare industry (may consider quality assurance, research, and development, operations, or related area).
• Ability to work within a team environment and accomplish projects within a fast-paced, matrixed environment.
• Strong verbal and written communication with the ability to communicate at multiple levels effectively.
• Proficient with MS Office suite (Word, Excel, Outlook)

Preferred:

• Advanced level degree
• Experience with medical device regulations and submissions
• Previous experience working in a highly matrixed and geographically diverse business environment

What Sciton will offer you:

• Competitive health and retirement benefits
• Time off
• Income Protection
• Professional Development
• Stock Options
• Discounted programs