Gloabl Medical Device SME Business. Home Based. Implement Post Market Surveillance process for products within the Wound Care Business Unit
Post Market Surveillance Manager - Regulatory Affairs - Medical Device
* Home Based Role - Must be willing to travel to sites in UK and Europe occasionally* Hold autonomy for the wound care business unit on an international scale * Competitive Salary
SRG partner with a global SME Medical Device company, specialising in the design, development, manufacture and distribution of high performing medical devices. Their portfolio is extensive, spanning wound care through to advanced surgical technologies.
Responsibilities:* Implement the Post Market Surveillance process for products within the Wound Care Business Unit* Expand Territories and maintain current registrations, licenses, Regulatory Certification, and submissions in accordance with local Regulations. * Support customer market registration activity, within the terms of existing contractual obligations. * Implement Regulatory Strategy and Vigilance process for the Wound Care Business Unit* Ensures adherence to vigilance reporting procedures according to applicable regulations or guidance.* Manage Wound Care Business Unit recall process* Provide leadership, personnel development, coaching, and mentoring to staff and to support the team to deliver to critical deadlines and manage their workload and time effectively.* Participate in company quality system audits and co-ordinating the regulatory inspection when it is required.* Ensure continued compliance to Global Vigilance and Medical Device Reporting processes
Skills and Experience:* Tertiary qualifications in a scientific discipline or similar field* Experience working in the medical device arena, preferably in a regulatory, post market position, alternatively in a QA role* Working knowledge of Global Regulatory Requirements, especially European and USA Experience in leading a team/managing people is preferred * Experienced in Medical Device Reporting and Vigilance* Excellent communication skills both written and verbally with employees, customers and suppliers.
Please contact me: Holly.Evans@srgtalent.com or +44 (0) 7909 207 693 for a confidential discussion around your career in Regulatory Affairs/Quality Assurance within the Med Tech arena.
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