In this role, you have the opportunity to
Provide Regulatory support the company's Emergency Care and Resuscitation business products. With advance expertise and knowledge of regulatory requirements you’ll developed and drive regulatory strategies for high tech medical devices.
You are responsible for
The Regulatory Affairs Specialist will provide timely and valued regulatory guidance (written and/or verbal) by owning the following tasks:
- Advise product design teams on regulatory strategy requirements for specific new products/solutions.
- Supports development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements and product registrations such as CE Marking and clinical evaluations.
- Develop and prepare product registration submissions for the US, Canada, EU and select worldwide locations.
- Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance.
- Identify potential regulatory approvals risks based on changes in regulations, standards, country specific issues or other unique characteristics of the project.
- Provide audit and CAPA support.
- Communicate application progress to internal stakeholders.
- Collaborate with worldwide colleagues regarding license renewals and updates.
- Maintain regulatory files and tracking databases.
- Collaborate with senior regulatory affairs specialists to create more complex submissions.
The company's Emergency Care and Resuscitation business products include hospital Automated External Defibrillators (AED)/Monitoring equipment and portable Emergency Services/Public Access and Home AEDs. Our devices are able to automatically detect and recognize shockable heart rhythms in victims of sudden cardiac arrest. These technological breakthroughs allow the clinician to concentrate more on the patient and less on the device.
To succeed in this role, you should have the following skills and experience
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
- Bachelor’s degree in a technical discipline, or equivalent experience.
- RAPS RAC preferred.
- Minimum of 5 years of regulatory experience in the medical device industry (EU MDD/MDR, Health Canada, US FDA class II and class III, etc.) or equivalent experience in a related field.
- Must have experience supporting class II and/or class III devices.
- Strong background in Design Controls and technical documentation.
- Successful preparation of domestic and international medical device license requirements.
- Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.
- Must be able to manage multiple tasks and perform with accuracy and a high attention to detail.
- Proficient computer skills in Microsoft Office.
- Effective working in multidisciplinary teams
- Good communication skills, written and verbal