To succeed in this role, you should have the following skills and experience. Yep it’s a long list but this is a Senior role.
- Bachelor’s degree (Master’s or Ph.D. 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 6+ years of experience in the medical device industry (EU MDD, Health Canada, US FDA class II and class III, etc.).
- Experience with software products preferred.
- Must have personal experience with successful preparation and submission of 510(k) and/or PMA submissions.
- Strong background in Design Controls.
- 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.
- 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.
- Experience in supporting international registrations and/or clinical investigations.
- Proficient computer skills in Microsoft Office.
- Understand LEAN concepts, methodologies and deployment.
- May require 5% travel annually with possibly some international.
Additional Info A Senior Regulatory Affairs Specialist. Medical Device experience is a hard requirement. We could possibly offer relocation assistance but prefer local. We are not considering remote employees but if someone is local and needs a day remote or so a week we can look into that. We are open on salary
Senior Regulatory Affairs Specialist
Don’t let this opportunity get away!
This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that’s not all. Quality is right on the top of our clients leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role’s mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment the Quality Leadership team has made and stands by.
Key Areas of Responsibility (KARs):
- Responsible for product registrations/approvals.
- Keep abreast of current regulatory procedures and changes. Participates in direct interaction with regulatory agencies on defined matters.
- Recommend and develop strategies and create detailed written regulatory plans for:
- IDE and Clinical trials applications in accordance with MDD Annex X, ISO 14155 standard.
- Traditional, abbreviated or special 510(k)s
- Pre-market Approval Applications
- Pre-submission applications
- Worldwide product registrations
- Responsible for the coordination and preparation of document packages 510(k) pre-market notification and PMA applications, technical file and design dossiers for CE marking, and worldwide product registrations.
- Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
- Drives improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System. Review and recommend changes for design process and manufacturing procedures to maintain quality and regulatory compliance.
- Provide audit support
- Provide guidance to business unit on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, ISO 13485 and ISO 14155, Canadian CMDCAS, compliance with FDA’s guidance documents etc.
- Strengthen and build clinical & regulatory capabilities.