• Ensure that products comply with applicable regulatory requirements.
• Creation of Design Input Requirements based on regulatory requirements and technical standards.
• Support creation of test methods and test protocols for Design Verification / Validation activities.
• Regulatory and/ or Engineering project management, especially supporting new design and development projects.
• Conduct Post Market Surveillance as per defined procedure.
• Conduct Review of Regulations and Standards, create gap analyses and communicate the outcome to other relevant departments.
• Prepare global regulatory approval submissions including 510Ks, PMAs, CE Technical Files, etc. 
• Ensure product labeling and claims meets regulatory requirements.
• Facilitate continual improvement process interfacing with all departments.
• Development and implementation of Regulatory-related training programs as required.
• Participate in internal and external audits.
• Evaluate Technical and Regulatory implications associated with product changes.

• University degree in Industrial / Biomedical Engineering
• 1+ year’s experience in the medical device regulatory affairs field 
• Commitment to excellence and high standards. Versatility, flexibility, and willingness to work with constantly changing priorities with enthusiasm
• Acute attention to detail. Demonstrated ability to plan and organize tasks 
• Communication skills, specifically the ability to convey technical information effectively, verbally and in writing
• Proficient on Microsoft Office products (Word, Excel, Access and PowerPoint)

• Prior experience with Medical Device Design Control
• Prior experience with Medical Device Regulatory Affairs
• Understanding of medical device labeling requirements
• Ability to handle multiple projects and meet deadlines
• Good judgment with the ability to make timely and sound decisions
• Creative, flexible, and innovative team player
• Working knowledge and understanding of the basic principles, theories, concepts, and practices in the applicable area of engineering/technical specialization
• Excellent written and oral communication skills
• Ability to work with all levels of management
• Strong organizational, problem-solving, and analytical skills
• Ability to manage priorities and workflow
• Knowledge of applicable regulations and standards

What we offer that you’ll love…

• Company Culture: At Nissha, we pride ourselves on cultivating an atmosphere of teamwork where all associates feel heard and valued. We may not all think the same, and we wouldn’t have it any other way.
• Diversity & Inclusion: We are committed to equity, racial justice, and equal opportunity for all.
• Training and Development opportunities: Because we foster a culture of continuing education. Let’s learn and grow together!
• Team Building, Connection, and Relationships: We support each other, celebrate our achievements and milestones together, and have FUN.
• Retirement: We know you want to retire comfortably and we’re here to help! Nissha offers a 401(k) Retirement Plan with an attractive employer contribution.
• Time Away from Work: Whether it is vacation or sick leave, we all need time to recharge. Paid time off is an essential associate benefit and a pillar of self-care.
• Engagement Activities: Recognition isn’t just a once-a-year occurrence at Nissha. We celebrate our team members year-round with summer picnics, holiday parties, and employee spotlight events, just to name a few.
• Commitment to Wellness: We offer various opportunities to learn about your health, be healthier, and get rewarded for your healthy lifestyle by offering reduced medical premiums.