Sr. Director of Quality and Regulatory Affairs
Job Details
Management
Full Time
Graduate Degree
Engineering
About the Job

As part of the Delve’s leadership team, the Sr. Director of Quality and Regulatory Affairs will be the focal point of coordinating Delve’s approach to world-class medical device design and development.  This is a new role tasked with leading, mentoring and growing Delve’s system engineering and quality engineering teams as well as collaborating with our multi-disciplinary design and innovation teams and clients in design controls, regulatory matters, best practices, and thought leadership.  

Medical device development is a key pillar in Delve’s current service offerings and our fundamental to our growth plans. This role will build on our heritage and experience to position Delve as the premier provider of design and innovation services to the med device community.

 

Responsibilities

  • Lead, mentor and grow our emerging systems engineering and quality management group by generating demand, satisfying clients, and fostering ongoing client relationships.
  • Lead the team responsible for Delve’s ISO 13485 certification including managing and maintaining our QMS and coordinating relevant training for our staff. 
  • Serve as the leader of our Medical Device Center of Excellence (COE) and be a focal point for sales and marketing, and "best practices" associated with medical device development
  • Support business development by being a credible, experienced resource that serves as Proposal Architect on key project opportunities
  • Champion continues improvement of our Design Control SOPs to ensure they strike the correct balance of rigor and efficiency.
  • Facilitate the continued expansion of our verification capabilities for both hardware and software with a combination of both organic growth and 3rd party partnerships.
  • Develop and execute on a strategy to continue to evolve and elevate our Regulatory experience to provide additional value to our Medical Device clients.
  • Keep Delve one step in front of emerging regulatory requirements such as Cybersecurity, IEC – 60601 updates, FDA guidance documents, etc.
  • Interact with our valued clients through meetings, presentations, design reviews and informal interactions - building trust and respect through a highly collaborative development process
  • Be a visible Thought Leader representing Delve’s Medical Device Development expertise via conference speaking engagements, blogs, committee participation, etc.
  • Have fun, doing cool work with good people and helping us support and grow our culture
About You

Requirements

  • Bachelor’s degree in related engineering or technical field
  • 15+ years' relevant experience in medical device development
  • Experience leading teams which execute projects under ISO 14971, FDA 21 CFR 820.30, ISO 13485, IEC 62366, etc.
  • Experience leading teams which are developing software per IEC 62304 and have experience in the creation and execution of software verification and validation protocols and reports.
  • Experience developing regulatory submission support documentation in the form of comprehensive Design History Files.

Preferred Experience 

  • You have experience working at organizations of various sizes (Startup to Fortune 500)
  • You have experience working for, or with consulting innovation and product development firms
  • You have experience in technical sales
  • You have a customer-centric attitude and personality
  • You have an entrepreneurial and growth mindset
  • You can balance the need for policy rigor and discipline with a pragmatic sense for efficiency and effectiveness in real-world day-to-day operations.  
  • You have exceptional oral and written communication skills with the ability to thoughtfully articulate and present technical ideas in formal and informal settings.
  • You are highly motivated, self-starter, able to manage multiple priorities.
  • You act with an inclusive mindset and model these behaviors for the organization.
  • You are motivated by change, and see the pandemic, social injustice, and our younger generations as meaningful opportunities to adapt how we design and collaborate, and what we deliver. Because equity, inclusion, and diversity are important to you, you have a point of view, personal or professional experience, or interest in helping make a difference.

 

Be inspired. Be inspiring. Be yourself.

Delve embraces difference because creativity, curiosity, and diversity drive innovation. We nurture a supportive and inclusive environment. Be yourself and create a future that improves lives. We encourage applicants of color and those with diverse lived experiences to apply.

 

About Delve


Delve is a multidisciplinary product innovation firm that brings bold ideas to market those guides clients through the complexities of innovation, delivering better, faster, and more sustainable success. For over 55 years, Delve has mobilized the best experts and technologies for its clients, completing over 10,000 client projects, producing over 1,500 patents, and winning over 200 design awards.

 

Delve serves ambitious start-ups to Fortune 500 clients in the healthcare, consumer, and commercial industries, delivering innovation through advanced expertise in research, strategy, design, and engineering. Delve has placed innovation studios in Boston, Madison, Philadelphia, and San Francisco to attract forward- thinking leaders to solve complex product challenges through human-centered design.

 

Apply