Company Description
Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time.
Role Description
As a Regulatory Affairs Specialist III, you will be primarily responsible for handling regulatory affairs requirements for medical devices. You will develop regulatory strategies and regulatory submissions for new and modified products to the FDA and International regulatory bodies. This individual will also provide regulatory support and guidance for product changes and is responsible for ensuring that product approvals are properly maintained, and product re-registrations are properly managed.
Primary Responsibilities:
Regulatory Compliance
- Ensuring regulatory compliance with QSR and cGMP requirements and stay apprised of FDA and EU requirements.
- Interpret and communicate regulatory requirements to internal teams.
- Monitor changes in regulations and update internal policies accordingly.
- Review of complaints for medical device reporting requirements.
- Evaluating changes to determine the filing requirements and impact on Product Registrations.
Documentation and Record Keeping
- Maintain accurate and up-to-date records of regulatory compliance activities.
- Prepare and submit regulatory documents, reports, and filings as required.
- Preparing documentation for international regulatory registrations
- Preparing technical documentation compliant to MDD and EU MDR
Product Compliance:
- Ensure that products meet regulatory requirements for safety, labeling, and quality.
- Review of labeling changes, and advertising and promotional material.
- Defining worldwide regulatory requirements necessary for regulatory approval of products. This includes writing, reviewing, and editing technical reports and regulatory documentation.
Communication with Regulatory Authorities:
- Interface with regulatory agencies and authorities to address inquiries and submissions.
- Respond to regulatory queries and requests for information.
Required Qualifications:
- Bachelor's degree in technical or scientific discipline; Master's degree or professional certification in Regulatory Affairs is a plus
- Minimum 2+ years’ experience in Regulatory Affairs with Medical Devices
- International registrations experience
- Experience in interacting with regulatory authorities.
- Familiarity with FDA, EU, Health Canada, and international regulations
- In-depth knowledge of relevant quality standards and regulations, including ISO 13485, ISO 9001, and 21CFR820.
- Ability to stay abreast of changes in industry regulations and standards, ensuring ongoing compliance.
- Ability to work collaboratively across different departments.
- Excellent communication and interpersonal skills, with the ability to effectively convey complex quality concepts to diverse audiences.
- Excellent oral and written communication skills in English.
- Able to travel domestically and internationally as required (<10%)
- Able to work in the US without sponsorship now or any time in the future.