Regulatory Compliance Engineer for Medical Devices

SharkNinja; Needham (MA); On-site; USD 72,700 - 111,400; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with matching

Generous paid time off

Job summary

SharkNinja, located in Needham, Massachusetts, is seeking a Product Compliance Engineer to oversee product certification processes. This includes collaborating with engineers and certification partners to ensure compliance with medical device regulations.

The ideal candidate will have a bachelor's degree in a relevant engineering field and 2–4 years of experience. The role involves managing multiple projects and understanding complex regulatory standards, with a competitive salary and a comprehensive benefits package offered.

Qualifications

• Minimum 2–4 years of relevant compliance or design-related experience.
• Working knowledge of FDA and EU medical device standards.
• Experience interfacing with regulatory bodies preferred.

Responsibilities

• Support certification activities for new product development.
• Assist with regulatory filings and maintain compliance documentation.
• Execute risk management activities across product lifecycle.

Skills

Biomedical/Bioengineering background

Systems Engineering experience

Knowledge of medical device regulations

Experience with DFMEA

Project management skills

Education

Bachelor’s degree in relevant engineering or technical field

Tools

ISO 14971

ISO 13485

IEC 60601-1 standards

Job description

SharkNinja, located in Needham, Massachusetts, is seeking a Product Compliance Engineer to oversee product certification processes. This includes collaborating with engineers and certification partners to ensure compliance with medical device regulations.

The ideal candidate will have a bachelor's degree in a relevant engineering field and 2–4 years of experience. The role involves managing multiple projects and understanding complex regulatory standards, with a competitive salary and a comprehensive benefits package offered.