Senior Manager, Regulatory


Summary: The Senior Manager, Regulatory is an important member of the Silk Road Medical Regulatory team with responsibility for coordinating and overseeing the timely preparation of world-wide regulatory submissions and product updates for our products and to facilitate the evaluation and approval process with the regulators to ensure timely approval of products.

Responsibilities: 

Strategic Planning:

  • Develop new regulatory policies, processes and SOPs to ensure compliance with latest regulatory regulations
  • Provide regulatory input to product lifecycle planning
  • Assist in the development of multi-country regulatory strategy, specifically APAC, and update strategy based upon regulatory changes
  • Utilize technical regulatory skills to propose strategies on complex issues
  • Determine submission and approval requirements
  • Identify emerging issues
  • Monitor trade association positions for impact on company products
  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams

Pre-market:

  • Assess the acceptability of quality, preclinical and clinical documentation for submission filing
  • Compile, prepare, review and submit regulatory submission to authorities; interact with regulatory authorities to answer questions in a timely manner
  • Monitor impact of changing regulations on submission strategies and update all appropriate departmental personnel
  • Monitor applications under regulatory review
  • Communicate application progress to all appropriate departmental personnel
  • 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
  • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
  • Provide strategic input and technical guidance on regulatory requirements to development teams

Post-market:

  • Oversee processes involved with maintaining annual licenses, registrations, listings and patent information
  • Ensure compliance with product post-marketing approval requirements
  • Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events
  • Actively contribute to the development and functioning of the crisis/issue management program
  • Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies
  • Report adverse events to regulatory agencies and internal stakeholders
  • Provide regulatory input for product recalls and recall communications

Minimum Qualifications, Experience and Skills Required:

  • BS in Life Sciences or other technical discipline preferred
  • Minimum 10 years of experience in a regulated industry, minimum 5 years of experience in regulatory affairs.
  • Excellent written and verbal communication skills.
  • History of successful Regulatory submissions including any required negotiations.
  • Knowledge of FDA, EU, APAC regulatory requirements.
  • Proficient in Word, Excel, PowerPoint and Adobe Acrobat.

Travel:

  • May require travel up to 20% of time.

What We Offer You:

  • A collaborative work environment with colleagues who care about each other and the success of their organization
  • A workplace where you are treated fairly, compensated competitively, and can learn and develop your skills
  • A chance to join an industry which is saving lives and changing the shape of healthcare
  • A very fun and supportive environment in a fast-growing organization where there is never a dull moment

Interested candidates should submit their resume to jobs@silkroadmed.com.

Join us!

  • ©2018 Silk Road Medical

  • 1213 Innsbruck Drive
    Sunnyvale, CA 94089

    phone: 855.410.TCAR (8227)
    local phone: 408.720.9002
    fax: 408.720.9013