Myomo, Inc Hiring for Document Control Lead – Medical Device Job at Boston, MA Full Time

This role will manage the day-to-day document control activities needed to sustain current business, assure document compliance, and support product development. The position also supports Regulatory and provides assistance to other Quality Department functions as needed. These functions could include activities such as Audit assistance, facilitation of employee training, review of DHRs, and other related activities.

*Flex for this role to be done hybrid/ remotely.

Responsibilities include but are not limited to:

Document Control Management:

• Manage the Document Control Database
• Provide direction and guidance to direct reports
• Facilitate the ARENA-PLM Operations and Tasks
• Screen, format and process Engineering and Document Change requests (ECRs and DCRs)
• Develop and update Bill-of-Materials with Engineering Department
• Effectively transfer Docs and CAD dwgs from Engineering into Document Control
• Organize and update documents in Dropbox locations
• Update all Files as needed and release new documents
• Standardize the format and content requirements of various documents
• Distribute and file documents for review and approval
• File and maintain records

Regulatory Assistance:

• Provide QMS Audit support and facilitation
• Assist in the collection, processing, and storage of Employee Training Records
• Assist in the collection, review, processing, and storage of Device History Records (DHR)
• Create and/or edit Forms and Procedure as required
• Maintain library of Regulations and Standards
• Gather data and run various surveillance reports as needed
• Provide other Regulatory assistance as required.

Qualifications:

• Bachelor’s degree or equivalent in a related major: business, graphic arts, technical writing, quality management, regulatory management, or similar.
• Work Experience in a Medical Device or Pharma Company
• 5+ Years in a Document Control Capacity
• 2+ Years providing direction and guidance to direct reports
• Proficient with utilization of Doc Control Systems and Data Bases
• Experience providing Regulatory Assistance
• Maintenance of UDI labels, IFUs, and Translation Activities
• Proficient with MS-Office Programs
• Self sufficient and ability to lead related tasks and projects
• Proven experience creating Templates, Forms, and Procedures

Myomo develops mobility solutions for people with neurological disorders. The MyoPro arm brace helps increase movement in weak, impaired arms. The company combines technology developed at Massachusetts Institute of Technology (MIT) with orthotics and prosthetics (O&P) professionals to help neurologically impaired people regain independence.

All qualified applications will receive consideration for employment without regard to race, color, ethnicity, religion, gender, national origin, disability and protected veterans status or any other personal characteristic protected by law.

Job Type: Full-time

Pay: $95,000.00 – $110,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Supplemental Pay:

• Bonus pay

COVID-19 considerations:
Employees are required to mask onsite.

Ability to commute/relocate:

• Boston, MA 02114: Reliably commute or planning to relocate before starting work (Preferred)

Education:

• Bachelor’s (Preferred)

Experience:

• Document Control Capacity: 5 years (Preferred)
• providing Regulatory Assistance: 2 years (Preferred)
• Medical Device or Pharma Company: 2 years (Preferred)

Work Location: One location