Regulatory Affairs Engineer
Regulatory Affairs Engineer
Posted on :
07-07-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Nissha Medical Technologies is excited to be hiring for a Regulatory Affairs Engineer to add to our team! This positionplays a key role in ensuring compliance of medical devices to FDA EU IEC ISO and other international requirements to ensure regulatory compliance across multiple manufacturing facilities. Combine knowledge of technical scientific legal and business requirements to assure products developed manufactured and distributed meet required statutory and regulatory requirements.
This position will advise on and coordinate the creation of Medical Device Design Input Requirements based on regulatory requirements and technical standards. This position will be a crucial link between Regulatory Affairs Design Engineering and Quality Assurance.
Nissha Medical Technologies is committed to fair competitive and market-informed pay for our employees. The pay range for this position is $70000-$80000 Annual (USD). The successful candidates particular combination of knowledge skills and experience will inform their specific compensation.
Essential Job Functions:
Requirements:
Why choose Nissha to build your career
At Nissha you can be assured that you will be part of a dynamic diverse team that is committed to bringing the best versions of ourselves each and every day. We recently received the General Excellence manufacturing award from Buffalo Business First which highlights our dedication to quality innovation and sustainability. This recognition celebrates the hard work of our team in producing high-quality medical devices that meet industry standards and enhance patient care. If you are looking for meaningful work that motivates and inspires youve come to the right place!
This position will advise on and coordinate the creation of Medical Device Design Input Requirements based on regulatory requirements and technical standards. This position will be a crucial link between Regulatory Affairs Design Engineering and Quality Assurance.
Nissha Medical Technologies is committed to fair competitive and market-informed pay for our employees. The pay range for this position is $70000-$80000 Annual (USD). The successful candidates particular combination of knowledge skills and experience will inform their specific compensation.
Essential Job Functions:
- 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.
Requirements:
- University degree in Industrial / Biomedical Engineering
- 1 years 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
Why choose Nissha to build your career
At Nissha you can be assured that you will be part of a dynamic diverse team that is committed to bringing the best versions of ourselves each and every day. We recently received the General Excellence manufacturing award from Buffalo Business First which highlights our dedication to quality innovation and sustainability. This recognition celebrates the hard work of our team in producing high-quality medical devices that meet industry standards and enhance patient care. If you are looking for meaningful work that motivates and inspires youve come to the right place!
What we offer that youll love
- Company Culture: At Nissha we pride ourselves on cultivating an atmosphere of teamwork where all associates feel heard and may not all think the same and we wouldnt 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. Lets 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 were 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 isnt 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.
And so much MORE!
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
