EU MDR/IVDR Project - Regulatory Affairs
* Company: Leading Orthopedic company based in Canton Zürich, Switzerland
* Position Type: Consultant (2 to 3 months), with option to be extended or permanent position
* Start Date: asap
Responsible for assisting the team with regulatory implementation of EU MDR. This position requires an advanced understanding of medical devices and their use as well as mastery of the regulatory framework in Europe, MDD 93/ 42/EC and MDR 2017/745.
This position specifically supports implementing the EU MDR globally for the company according to the project plan.
General Duties and Responsibilities:
* Applies regulations to business practices and provides regulatory input, advice and guidance as needed
* Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products, under the new EU MDR
* Write, refine, track and coordinate Regulatory corporate procedures for harmonization of implementation of EU MDR
* Prepares training materials and guidance documents to Regulatory Affairs professionals, supporting implementation of EU MDR
* Follows Company's regulatory affairs policy and procedures
Expected Areas of Competence
* Demonstrated strong writing, communication, and interpersonal skills
* Strong attention to detail
* Ability to manage several competing priorities; versatility, flexibility, and willingness to work with changing priorities
* Proficient knowledge of overall business environment, the orthopedic industry, and the marketplace
* Proficient knowledge of European/MDR-related regulations pertinent to medical devices and biologics
* Ability to build relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels
* Mastery of current EU regulations and proficient knowledge of other global regulations
* Ability to identify risk in Regulatory strategies
* Proven analytical and negotiation skills
* Experience with solving problems and concerns
* Intermediate computer skills, including Microsoft Office Suite
* Ability to communicate efficiently
* Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred
* A minimum of 2 years year of experience in orthopedic or medical device industry preferred
* A minimum of 5-7 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
* Experience in authoring of technical documentation (DHF, Risk Management, RA Submisssion docuemnts)
* A combination of education, experience, leadership, strategy, and RA influence may be considered
Project-Specific Responsibilities/Work Description:
* The Regulatory Affairs Senior Specialist will perform work as directed by the MDR Project Regulatory Affairs leadership (Work stream lead) using the MDR Project methodology, execution plan, and objectives.
* The Senior Specialist will be expected to work effectively with minimal supervision and maintain strong ownership of project deliverables and timeline
* Functional areas under the MDR Project's Regulatory Affairs Work stream include a corporate functional area and functional areas focused around Company's Business Units. There will be cross functional interaction and collaboration required between functional areas within the Regulatory Affairs Work stream as well as between other MDR Project Work streams
* The Regulatory Affairs Senior Specialist will be assigned to lead a specific functional area, subject to change as project needs develop. The Regulatory Affairs Senior Specialist will directly report to the Regulatory Affairs Work stream Lead
* Objectives & Deliverables
* Objectives and deliverables will be defined by the MDR Project Regulatory Affairs leadership.
Roles & Responsibilities
* Have a proficient understanding of the EU MDR and be able to apply MDR concepts to daily work and processes
* Able to foresee and communicate potential project risks and opportunities based on understanding of the MDR and own experience and offer solutions.
* Interface with and influence cross functional groups outside of the MDR project as needed to ensure project work is completed per plan.
* Communicate regularly with the Regulatory Affairs Work stream lead on project progress, ensuring timely communication of successes, risks, and challenges.
* Stay abreast of developing MDR regulations and work closely with the Intelligence Team.
* Corporate Functional Area
* Review corporate procedures for MDR impact and update to ensure compliance with MDR.
* Create new procedures to ensure global compliance with MDR, as needed.
* Create standardized templates to be used in the MDR project for EU Technical Document creation.
* Ensure Regulatory Affairs requirements for MDR are incorporated into global systems (e.g., design control, risk management, etc.) through cross-functional communication and teamwork.
* Business-specific Functional Area
* Work closely with Regulatory Affairs experts within the Business Unit to identify all MDR gaps and
* Support Product Classification activities, for harmonized approach
* Work with cross-functional teams within the Business Unit to drive updates to the new MDR requirements as needed.
If you are interested in this position, please contact me as soon as your earliest convenience, as i already have interview dates scheduled.
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