CAREERS
Job Title: Quality/Regulatory Associate
A medical device company with headquarters in Beverly, Massachusetts, is an up-and-coming provider of innovative spinal surgery devices for use by spine surgeons around the world. Our company is driven by surgeon ingenuity that will improve patient’s quality of life. Our entrepreneurial environment places great emphasis on fostering innovation, creativity, and teamwork. Our enthusiasm is founded on an open spirit and a passion for results. Our business is built on people from different backgrounds, coming together for a common goal.
We are looking for an experienced Product Development Innovation Manager to work with a cross-functional team to design innovative surgical implants and instrumentation by performing the following duties:
ESSENTIAL DUTIES:
- Providing quality and regulatory input to product development teams
- Leading risk management efforts for product development teams
- Ensuring compliance with design controls throughout product lifecycle
- Assessing and determining regulatory impact of proposed design changes
- Planning and supporting development of regulatory submissions
- Conducting investigations and documenting assigned complaints
- Travel – 10%
QUALIFICATIONS
- 3-5 years in quality or regulatory role in a medical device company, Spine preferred
- B.S. in engineering or sciences
- Strong knowledge of the QSR, ISO 13485, and MDD
- Successful history serving as QA/RA representative on product development teams
- Experience supporting successful regulatory submissions, including 510(k), IDE, and PMA
- Ability to work in an extremely fast paced and dynamic environment
*We offer tremendous room for advancement and income potential.
All submissions will be held in the strictest confidence. This position is being sought after for immediate hire.
SpineFrontier is an Equal Opportunity Employer.
Please submit your resume and cover letter to mycareers@spinefrontier.com