Regulatory Affairs / Quality Assurance Engineer Intern
IMP SCANDINAVIA is a MedTech Start-Up that develops new intelligent monitoring technology to remotely monitor patients in the healthcare sector. The goal is to increase the quality of life for patients, to streamline the supervision and monitoring of patients, and to improve the health-related decision-making.
The RA&QA Engineer will assist the establishment and maintenance of IMPs Quality Management System to support company quality policies and goals and maintain operations that efficiently and effectively surpass strategic business planning objectives. The RA&QA Engineer is also responsible for identifying, evaluating, and ensuring meaningful compliance with all applicable laws, regulations, and standards. Efforts to ensure company compliance shall be inherently established within IMPs Quality Management System. The RA&QA Engineer shall follow the guidance of RA&QA Management and help other specialized organization functions understand and fulfill their obligations to meet quality objectives, systemic responsibilities, and customer requirement policy, as defined by Executive Management in IMPs Quality Policy. As part of the maintenance of the IMPs Quality Management System, the RA&QA Engineer shall partake in all of the following responsibilities:
- Routinely pursue more efficient and effective operations (continual improvement).
- Participate in Supplier Management activities, as required.
- Provide Quality System guidance to IMPs integrated product teams, including Design Controls, Risk Management, and all associated processes, policies, procedures, and records. Ensuring proper activities are completed in a timely manner, performed and documented correctly, and readily offers guidance and support to ensure Quality System compliance.
- Assume responsibility for completion of an annual share of Internal Quality Audits.
- Participate in the development of Management Review Presentations and participate in 3rd party audit and inspection activities (ISO, MDR, etc.)
- Coordinate the creation, execution, and validation of all change orders and ensure that reasonable risk management controls are in place.
- Collaborate with engineering to determine and execute engineering Design History Files plans in support of regulatory submissions.
- Review all Engineering Change Requests and Engineering Change Orders to ensure sound engineering practice, effective and adequate design, product safety, and Quality System compliance.
The RA&QA Engineer shall support continual visibility over the development of legal and regulatory enactments, identify company improvements or activities necessary to ensure compliance, and ensure that the company establishes controls and/or completes necessary activities to ensure compliance. Further, the RA&QA Engineer shall support reviews of all and all future target markets to ensure knowledge and fulfillment of establishment registration, device licensing, surveillance, adverse event and corrective action reporting, translation, product standards, and all other requirements necessary to support import, sales, distribution, installation, and support in all chosen distribution markets. This includes:
- Remain aware of new or updated regulations, laws, standards and other official enactments that may apply to the company.
- Provide detailed analysis, official recommendations, and gap analyses for new or revised enactments.
- Assist the submission of medical device adverse and field corrective actions reports and recall notifications.
- Ensure adequate compliance schemes associated with all regulatory compliance systems, as required by law.
- Support and coordinate all regulatory product clearance submissions.
- Assist in the submittal of registration applications.
- May interface with MDR and other regulatory agencies regarding regulatory submission strategy and approval reviews, as per company marketing plans.
Your daily tasks will be designed in close corporation with the CEO and CTO.
Minimum educational, training, and experience qualifications:
- A Bachelor of Science Degree in mechanical engineering, industrial engineering, or other related science activity.
- Familiar with practice of RA&QA skills and activities.
- Interested in MDR Quality Systems Regulations, ISO standards, information privacy and security, environmental controls, and /or similar compliance schemes.
- Interested in a regulated manufacturing environment as a Compliance Engineer (medical devices preferred) or equivalent.
- Interested in medical device development under MDR Quality Systems Regulations, European Union Medical Device Regulations, CE Marking process, and ISO standards.
- Demonstrated results in improving quality within an ISO certified manufacturing environment.
What we offer?
We offer the following:
- You will be joining a team of young passionated people and will have an impact on our business.
- Flexible working-hours: Time is precious. Make it count.
- Remote work allowed: You know how you perform best.
We value a great eager to learn and a positive energy very high, so please apply even if you can only check one or two of the points. As a part of the IMP team, you can expect lots of responsibility and challenges that will make you grow professionally and personally, social events, and a letter of recommendation. For more information or questions please contact us at Oka@impscandinavia.com or phone number +45 28 14 88 38.
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