PROVIDENCE is advancing cervical spine fusion. Our purpose is to build a passionate team that delivers innovative spinal technology to help patients enjoy pain-free lives. Providence has pioneered a proprietary approach to posterior cervical fusion and has developed surgical instrumentation and implants that offer unique benefits to the $2 billion worldwide cervical spine market. Our family of spinal instruments and implants address unmet clinical needs and offer advantages to patients, surgeons, facilities, and payers.
We are seeking a DIRECTOR, QUALITY & REGULATORY AFFAIRS to join our growing team. Candidates should embody our core values of: Team, Passion, Innovation, Quality, and Transparency. We value highly motivated and resourceful team players who take pride in consistent excellence and continuous improvement.
The DIRECTOR, QUALITY & REGULATORY AFFAIRS ensures departmental activities run smoothly at the discretion or direction of the Chief Operating Officer. The Director RA should exhibit all of the company’s core values both within the company and externally at all times.
IN THIS ROLE YOU WILL:
With QA, lead and manage inspections by regulatory agencies.
Provide education, communication and consultation of regulatory requirements throughout the organization as appropriate.
Ensure products are properly marketed per US FDA and international and regulations.
Ensure marketing and sales material complies with FDA, internal and all applicable regulations based on product clearances, approvals, and regions.
Draft and submit, and/or coordinate with or take direction from consultants, 510(k) and other US submissions to support product commercialization.
Draft and submit, and/or coordinate with or take direction from consultants, OUS registrations to support expansion into key markets.
If required, lead recall and field action communications and reconciliation including follow-up with US and international agencies.
Support R&D, Marketing and Operations as products are introduced and iterated to ensure new products meet and product changes comply with regulations.
Support Technical File development and release to support CE marking in the EU.
Work with R&D and Operations to compile, review and approve DHRs and ECOs.
Manage complaint process, including tracking, notification and resolution
Lead and communicate changes in regulations and standards to ensure proper compliance through the product development to commercialization.
Support the implementation and maintenance of the QMS.
Support planning, development and maintenance of company initiated clinical studies.
Communicate with distributors and international agencies to initiate and maintain OUS registrations.
Participate in risk management activities.
Manage audits and support regulatory inspections of contract manufacturers, vendors and test labs; Including planning, scheduling and supporting audits to assure adherence to company quality policies and applicable regulatory requirements
Conduct quality and process audits, including internal audits.
Other duties may be assigned.
YOU ARE QUALIFIED FOR THIS POSITION IF YOU HAVE:
4-year degree in applicable field of study. B.S. or B.A. in the field of science preferred.
7+ years of regulatory experience in medical devices.
Regulatory experience with orthopedic and/or spine products preferred.
RAP Certification preferred but not required.
Experience with QMS implementation and maintenance preferred.
Experience with clinical studies desired.
Must be experienced with FDA 510(k) requirements and submissions.
Must be experienced with EU CE marking.
OUS registration experience desired.
REQUIRED SKILLS AND ABILITIES:
Excellent attention to details and verbal and written communication skills.
Must be able to work collaboratively in a team environment.
Must be able to self-mange and work independently in a start-up environment with high energy.
Must have good Microsoft skills (e.g. Word, Excel, Visio, PowerPoint, etc.).
Minimal travel routinely required but may need to travel to support submissions and discussions with agencies or as the need arises to support the core business.
Internal Number: Q3-18 (113)
About Providence Medical Technology
Providence Medical Technology, Inc. is a privately-held medical device company focused on innovative solutions for cervical spinal conditions. The company has pioneered a proprietary approach to cervical fusion and has developed surgical instrumentation and implants that offer unique benefits to the $2 billion worldwide cervical spine market.
The Providence family of products includes the DTRAX® Spinal Instrumentation System, CAVUX® intervertebral implants, and the ALLY® line of bone and facet screws. All products are shipped-sterile and single-use to maximize perioperative efficiency and ensure consistent quality and performance.