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.
- 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
- 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
- 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.
- 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 firstname.lastname@example.org.