Regulatory Manager/Sr. Manager

Welldoc®, a digital health leader revolutionizing chronic care, is integrating personalized, real-time, and actionable insights into the daily lives of individuals living with chronic conditions. Our current mission is to propel chronic care by empowering healthcare stakeholders to extend face-to-face models with an adaptable chronic care platform that fits into any delivery scenario and supports optimized health and cost outcomes.

Our comprehensive chronic care platform provides multi-condition support across diabetes, pre-diabetes, hypertension, heart failure, and behavioral health. Welldoc’s flagship product, BlueStar®*, an FDA-cleared digital health solution, guides individuals through the complicated journey of living with diabetes by enabling them to self-manage their care while enhancing connections to their healthcare team.

At Welldoc, we are focused on transforming healthcare by creating an environment that fosters collaboration, learning, and innovation. We value the personalities and experiences of every one of our team members, giving everyone the opportunity to thrive as we make our mission a reality.

If you are inspired by innovation and the power of cutting-edge science to help individuals live healthier lives, we would love to hear from you!

*Welldoc Diabetes Rx/OTC is an FDA-cleared medical device (“BlueStar”), intended for use by healthcare providers and their adult patients with type 1 or type 2 diabetes. For full labeling information, visit www.welldoc.com. The other Welldoc products are non-FDA-cleared and intended to promote general wellness and education/self-management of various chronic disease states.

Job Purpose

The Regulatory Affairs Manager will represent the regulatory function across all lifecycle phases of software medical devices.

Responsibilities

• Represent regulatory affairs in new product development activities
• Prepare and prosecute regulatory submissions for US (FDA), Canada (Health Canada), and EU (Notified Body)
• Collaborate with cross-functional new product development teams to identify regulatory requirements and guide products through the appropriate regulatory pathway to market
• Assess changes to released products and comply with regulatory notification requirements. 
• Establish policies and procedures for determining regulatory pathway for new devices and changes to existing devices and update as necessary to maintain compliance with latest regulations and guidance.
• Assess marketing materials for regulatory compliance
• Lead third party audits and inspections as they relate to medical device regulatory matters
• Define priorities, plan work to support projects, delegate responsibilities, and balance longer-term efforts with day-to-day demands.
• Proactively monitor for changes to applicable regulations and consensus standards and address any resulting gaps in operating procedures or product technical documentation as necessary. 
• Support post-market surveillance and vigilance regulatory activities
• Maintain device and facility registrations

Required Skills & Experience

• 6+ years’ experience in a medical device regulatory role
• Experience with Software as a Medical Device (SaMD) or devices with a significant software component
• Experience preparing and prosecuting global medical devices premarket submissions. Experience with US Class II, Canada Class II, and EU MDR Class IIa/IIb preferred (i.e. 510(k)’s, MDL Applications, and MDR Technical Documentation)
• Experience assessing and documenting device classifications and regulatory pathways to market for new devices and device modifications
• Practical knowledge of ISO 14971, ISO 13485, IEC 62304, IEC 62366
• Knowledge of US FDA SaMD regulations and policies including experience differentiating regulated medical device functions from other functions and assessing the impact of other functions on medical device functions.
• Attention to detail and good documentation practices
• Ability to work autonomously
• Experience in key QMS areas including design controls, risk management, vigilance, and post-market surveillance
• Excellent verbal and written communications skills
• Demonstrated ability to translate regulations or regulatory guidance into internal policies, procedures, and work instructions
• Comfortable working in a fast-paced and agile environment
• Experience with conducting or maintaining clinical evaluation per MEDDEV 2.7/1 Rev. 4
• Knowledge of global cybersecurity and privacy regulations, consensus standards, and guidance a plus

Required Education                                       

• BS degree in a relevant science or engineering field

 Compensation & Benefits

WellDoc offers a competitive compensation package including generous PTO, pre-IPO stock options, medical insurance, dental plan, vision care, flexible spending account, and 401(k) benefits.