Regulatory Affairs Specialist - Start Up

Sigmar Recruitment

Galway

The Regulatory Affairs Specialist helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. Specific emphasis for this role will be US FDA submissions. PRimary Responsibilities : Maintain an excellent understanding of global medical device regulations, for specific jurisdictions, primarily in accordance with specific FDA guidance & MDD 93/42/EEC. Develop global regulatory strategies in collaboration with regulatory affairs management. Plans and prepares regulatory submissions with specific emphasis on US FDA, i.e. 510(k), HDE, IDE and PMA submissions. Communicates directly with regulatory authorities to ensure product approvals are achieved in a timely manner. Maintains registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability. Provides ongoing support to currently marketed products as necessary including input on change notifications, etc. Ensures a thorough understanding of the products they are assigned. Can act as a designee for the RA management, if required. Secondary Responsibilities : Lead the Design Review process in compliance to internal procedures including EU and FDA requirements. Maintain the Design History files, including managing the filing, storage and retrieval of Design Quality Records. Ensure all product quality standards and specifications are defined and achieved in line with company and Regulatory requirements including MDD 93/42 EEC and FDA requirements. Lead risk management process and preparation of risk management files including Use and Design FMEAs as required. In conjunction with the design teams identify product testing required and write design verification and validation plans, protocols and reports including specifically advising on sample sizing; including but not limited to Ethylene Oxide sterilization, Biocompatibility, Stability and Transportation testing. Preparation of Standard Checklists for all the applicable main harmonized standards. Core Competencies Required Proven success in the following job competencies: Application of standard regulatory requirements. Change control management; design, process and system. Communication, Presentation and meeting chairing. Customer Focus. Medical Device Industry and/or Profession Expertise. Problem Solving and Decision Making. Quality of Work; maintains high standards despite pressing deadlines. Risk Management. Design Verification including Ethylene Oxide sterilization, Biocompatibility, Stability and Transportation testing. EXPERIENCE Minimum 5 years’ experience in Regulatory Affairs, Design Assurance or similar role in a medical device company. Primary and/or a postgraduate degree BS, MS, or PhD (Mechanical, Materials, Polymer, or Biomedical Engineering, or related technical field. Knowledge and demonstrated practice of risk management methodologies as per EN ISO14971. Working knowledge of FDA requirements including Quality System Regulation (21 CFR 820), the Medical Device Directive (93/42/EEC) and applicable harmonised standards and the ability to apply them in practice. Previous experience with submissions to US FDA is a distinct advantage. Please call Fiona McLoughlin on 091455303 or send an updated CV to fmcloughlin@sigmar.ie. This job originally appeared on RecruitIreland.com.

2452 days ago