Be a part of a global team where what we do matters! At Epredia, we recognize that our talented employees are vital to our success. Our team is dedicated, our work is rewarding – both personally and professionally – because what we do matters.
We seek talented individuals who will contribute to and thrive in our collaborative, diverse, fast-paced environment while demonstrating a commitment to our core values, People, Customer, Results, Continuous Learning, and Innovation.
People – We win as a team.
Customer – We deliver customer-centric solutions.
Continuous Learning – We learn and always aim to be better.
Innovation – We innovate every day.
Results – Results matter for all of us.
Position Summary:
This role manages the regulatory affairs function for Richard-Allan consumables and Shandon Diagnostic Instrumentation, ensuring regulatory compliance for Epredia's manufacturing site and device portfolios to support and maintain global market access. The Regulatory Affairs (RA) Specialist escalates all regulatory matters to the Global RA Director (Heather Gallacher) and is responsible for supporting global registration activities for instrument and consumable device portfolios.
What you will do:
Regulatory Support – Shandon Diagnostics & Richard-Allan Scientific:
- Ensure regulatory compliance of the manufacturing site, supporting site operations accordingly.
- Approve regulatory processes and documentation related to new product development, product changes, improvement projects, and marketing materials.
- Support global product registration efforts for devices.
- Prepare and maintain technical documentation including DoC, GSPR, and related files.
- Contribute to the Health Hazard Assessment (HHA) process as part of Post-Market Surveillance (PMS) and Vigilance activities related to site complaints and quality issues.
- Support the site’s Quality Management System (QMS), including audits, regulatory SOPs, complaint investigations, and documentation/labeling review, approval, and release.
- Lead regulatory activities for site projects, including new product development and manufacturing transfers.
- Maintain regulatory intelligence at the manufacturing sites; conduct training sessions as needed, including those on new regulations.
- Complete EMEA registration requests for the instrument and consumable portfolios (new and existing devices).
- Complete or support registration requests across the entire Epredia portfolio, as needed
Qualifications & Skills:
- Scientific degree with over 1 year of experience in In Vitro Diagnostic Medical Devices (IVDs).
- Working knowledge of global regulations preferred (US FDA, EU IVDR, and Rest of World).
- Spanish fluency (written and spoken) is beneficial not essential.
- Strong attention to detail.
- EMEA registration experience.
- Clear and effective communication skills.
- Ability to interpret and apply regulations to business-specific scenarios.
- Competent in creating project plans, timelines, and regulatory strategies; skilled in organizing and tracking complex regulatory data.
- Familiarity with ISO 13485 and global IVD regulations (US and EU).
- Capable of managing multiple projects and competing priorities.
- Exercises sound, ethical judgment within company policies and regulatory frameworks.
- Willingness to travel internationally up to 10%.
TO ALL RECRUITMENT AGENCIES: Epredia does not accept unsolicited third-party resumes.
Building an Inclusive Culture: We are a company that brings the best people together and leverages their varying backgrounds, ideas, and points of view to invent on behalf of all customers. We are committed to equal employment opportunity for all individuals, without regard to race, color, national origin, ancestry, sex, age, religion, physical or mental disability, medical condition, veteran status, marital status, pregnancy, sexual orientation, gender identity, genetic information or any other protected classes which may exist under applicable federal, state or local law.