The Regulatory Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks:
1. Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
2. Create detailed written regulatory plans that can be used to target domestic and international shipment dates.
3. Develop and prepare product registration submissions for the US, Canada, EU and select worldwide locations.
4. Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance.
5. Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
Additionally, the Regulatory Specialist will:
• Communicate application progress to internal stakeholders
• Maintain regulatory files and tracking databases as required
• Provide audit support
• Bachelor’s degree (Master’s preferred) preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry.
• RAPs RAC strongly preferred. ASQ certifications also desirable.
• Minimum of 5 years of experience in the medical device industry (EU MDD, Health Canada, US FDA class II and class III, etc.).
• Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations and standards, including ISO14971, IEC 60601 and related particular standards.
• Preferably personal experience with successful preparation and submission of 510(k) and/or PMA submissions.
• Experience writing Clinical Evaluation Reports (CERs) that are compliant with MEDDEV 2.7.1 revision 4 highly desirable.
• Knowledge of the nature and impact that the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) will have on Manufacturers and Notified Bodies.
• Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision
• Proficient knowledge of domestic and international standards.
• Strong background in Design Controls.
• Must be able to manage multiple tasks and perform with accuracy and a high attention to detail.
• Understand LEAN concepts, methodologies and deployment.
Furthermore to be successful in this role you are :
• Motivated, self-driven with a determination to succeed and the ability to manage change.
• Analytical, you are open to new ideas and believe in continuous learning in order to develop new competencies.