Company: Regulatory Professionals
Location: Basel, Switzerland
Closing Date: 12 May 17
Type: Full Time
Salary (£): On Application
Regulatory Affairs & Compliance Manager My Client is a global leader in the development and manufacturing of dental implant systems, with headquarters in Switzerland. They are looking for a Regulatory & Compliance Manager to join their product development team based out of Basel.
Regulatory Affairs & Compliance Manager
My Client is a global leader in the development and manufacturing of dental implant systems, with headquarters in Switzerland. They are looking for a Regulatory & Compliance Manager to join their product development team based out of Basel.
Participate on assigned product development teams by representing and reinforcing Design Control, Quality Assurance and Regulatory Affairs requirements.
Author the Regulatory Strategy for assigned products in consultation with the International Regulatory Affairs team and in-country subsidiaries as needed.
Define product classification and regulatory pathway in EEA and United States for assigned products.
Review and approve Design History Files to assure compliance with client"e;s design control requirements, ISO 13485 and other applicable standards and regulations.
Create regulatory submission documents for the United States [510(k), PMA].
Assess, review and approve product and process change requests, in consultation with International Regulatory Affairs, to assure that all necessary regulatory activities are addressed prior to change implementation.
Manage interactions with notified bodies, competent authorities and other regulatory bodies as appropriate to achieve and maintain market access for assigned products.
Consult to the International Regulatory Affairs team as necessary to achieve market access in markets other than the EEA and US.
Represent Quality and Regulatory as appropriate during internal audits and third-party audit/inspection of design control activities.
The Ideal Candidate:
Technical or scientific degree or equivalent experience.
Minimum 3 years of experience in premarket RA or product development QA.
Knowledge of the standards and regulatory requirements for medical products.
Fluent written and spoken English; experience with German valuable.
Effective verbal and written communication.
Perceptive with strong analytical skills.
Understand and able to achieve the demands of rapid product development cycles.
Traits: honest, positive, motivated, inquisitive, able to see the humor in situations, customer-driven, solution-focused, systems-oriented and emotionally intelligent.
This placement will be managed by our Swiss Partner Sigma Management Services
Medical devices; medical technology; diagnostics; Regulatory; RA; Consultant; Consultancy; biotechnology; affairs; regulatory affairs; Specialist; officer; manager; ; Germany; English; German; MDD; compliance; FDA; 510(k); 21; CFR; 820; 14971; 13485; Quality; Risk; Management; CE; Marking; CE mark; dossier; Notified body; IVD; In Vitro Diagnostic; IVD; EMEA; Americas; APAC;
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