Regulatory Affairs Specialist I

Who we are

Silk Road Medical, Inc. is a medical device company located in Sunnyvale, California & Plymouth, MN, that is focused on reducing the risk of stroke and has pioneered a new approach for the treatment of carotid artery disease called TransCarotid Artery Revascularization (TCAR).

We are always looking for dynamic and innovative individuals who are passionate about reducing the risk of stroke. We welcome team members who approach their work with courage, flexibility, persistence, and a willingness to assist others with a strong emphasis on collaboration.

The opportunity

The Regulatory Specialist supports, develops and drives the timely preparation of regulatory submissions and product updates necessary to obtain and maintain regulatory approvals for Silk Road Medical products. This position will support the regulatory strategy, review of design changes, manufacturing changes and specification changes.

This is a hybrid position.

A "Day in the life"

• Support and maintain regulatory processes and SOPs to ensure compliance with latest applicable regulations.
• Provide regulatory input to product lifecycle planning.
• Support fulfillment of submission and approval requirements.
• Support risk management activities.
• Keep abreast of new or revised regulations, proposed regulations and guidances, compliance guides, journals, etc. and determine the impact, if any, to Silk Road Medical products.
• Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
• Compile, prepare, review, and submit regulatory submissions to regulatory authorities.
• Monitor impact of changing regulations on submission strategies and communicate to appropriate departmental personnel.
• Monitor applications under regulatory review.
• Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities.
• Evaluate proposed preclinical, clinical, design and manufacturing changes for regulatory filing strategies.
• Review proposed post-market changes to determine the level of changes and any resulting submission requirements.
• Complete and update Technical Files / Design Dossiers necessary for product continuance.
• Support processes involved with maintaining annual licenses, registrations, listings, and patent information.
• Support compliance with product post-marketing approval requirements.

What you'll bring

* Bachelor's degree in related field or equivalent education and experience.

* Prior experience in medical device required, regulatory affairs experience preferred.

Additional skills you have

• Excellent written and verbal communication skills.
• Knowledge of FDA, EU, APAC regulatory requirements.
• Proficient in Word, Excel, PowerPoint and Adobe Acrobat.
• Must be detail oriented.
• May require occasional travel (5%-10%)

Come join our team where we celebrate diversity and embrace everyone's unique talents! We encourage individuals from all backgrounds to apply.

What we offer

Our philosophy is to make all benefits affordable to all Silk Road Medical employees and their dependents. We offer robust and affordable benefits with modest employee contributions. Click here for more information .

Actual compensation for this role depends on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience with the job, industry, and related education, etc. Silk Road Medical is a multi-state employer, and this salary range may not reflect positions in other states. The anticipated compensation range for candidates who will work in Sunnyvale, CA is $66,000 - $82,500. This position will also be eligible to participate in our annual bonus and earn equity in accordance with company policy. In addition, we offer robust and affordable benefits with modest employee contributions.

Our Commitment to Diversity, Equity & Inclusion

We welcome all people who want to be part of our amazing journey and mission to provide new, innovative, and clinically proven transcarotid therapies to prevent the devastating burden of stroke. Our employees come from very different backgrounds: different races and ethnic backgrounds, different religions, and different parts of the world. Some of us are married to people of the opposite sex and some to the same sex, some are not married. Some of us are becoming parents for the first time and others are counting down the days to retirement. Some of us do cartwheels every day and some need physical accommodation to best perform their role. All are welcome.

We have a diverse workforce because we believe that it is possible for people with different backgrounds, viewpoints and persuasions to come together and debate important topics, learn from one another, and make better decisions than we would if we all were all the same. We want Silk Road Medical to not only be a great place to work, but The Greatest Place to Work and we strongly believe that a diverse and inclusive working environment is critically important to that goal.

Actual compensation for this role depends on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience with the job, industry, and related education, etc. Silk Road Medical is a multi-state employer, and this salary range may not reflect positions in other states. The anticipated compensation range for candidates who will work in Sunnyvale, CA is $66,000 to $84,000. This position will also be eligible to participate in our annual bonus and earn equity in accordance with company policy. In addition, we offer robust and affordable benefits with modest employee contributions.

Silk Road Medical is an equal opportunity employer and we value diversity at our company. We strictly prohibit unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity, national origin/ancestry, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.