Medical Device Regulatory Strategist
Vor 6 Tagen
About MedTech Innovator
We are a pioneering medical device company that leverages cutting-edge technology to revolutionize the surgical experience. Our team of innovators and experts shares a common vision: to make on-demand robotic surgery a new standard in medicine.
We take pride in fostering an inclusive, diverse, and dynamic work environment where talented individuals from various backgrounds come together to drive growth and progress.
If you are looking for a stimulating challenge in a rapidly evolving field, join us in shaping the future of minimally invasive surgery.
Job Summary:
The Regulatory Affairs Specialist is responsible for spearheading substantial and complex regulatory projects within our organization. This role plays a crucial part in ensuring our products and services comply with relevant regulations, meet the needs of our patients, customers, and regulators, while maintaining our internal QMS and global regulatory requirements.
Main Responsibilities:
Support our products in global markets by authorizing and organizing regulatory documentation for submissions, notifications, renewals, establishment registrations, product listings, and letters to file.Plan and coordinate activities with cross-functional partners to ensure achievement of project objectives and milestones related to planned regulatory submissions.Maintain CE Technical Documentation as per EU Directive and Notified Body requirements.Identify and comprehend all applicable regulatory and legal requirements.Adhere to standardized processes for product classification assessments and regulatory product change evaluations, including assisting in the development of regional regulatory strategy and execution.Collaborate with relevant team leaders and subject matter experts to plan, execute, and document required clinical and non-clinical tests.Ensure consistency between the DHF and submission file with the expectations of the FDA, MDR, and other national or local regulatory requirements.Act as a subject matter expert to advise our QA team in making the QMS compliant with FDA and MDR requirements.Seek support when necessary and interact with external consultants and third parties.Represent our company, products, and processes in communications and meetings with regulators (e.g., FDA, Notified Body).Serve as the point of contact for regulatory matters with external partners (distributor, legal agent, EC Rep, Importer).Other duties as assigned.Work Experience and Education Requirements:
Bachelor's degree; advanced degree preferred.Minimum 5 years of regulatory affairs experience within the medical device industry in a global environment, including Europe and USA.Key Skills and Qualifications:
A working knowledge of FDA and MDR regulations, including experience with premarket notification (510(k)) and technical documentation.A working knowledge of FDA Quality System Regulation (21 CFR 820), EU MDR, ISO standards, and the ability to apply them in practice.Excellent communication skills across all levels of the organization with the ability to influence through constructive and collaborative means.A team player with a flexible and creative approach.Scientific rigor, attention to detail, and analytical and synthesis skills.Demonstrated computer skills, strong written and interpersonal communication skills.Ability to excel in a fast-paced, dynamic environment undergoing significant growth and change.Passionate about talent development, coaching, and mentorship.Experience in large-scale organization change efforts.Experience working within and across a matrixed organization.Benefits:
An opportunity to work in a fast-growing company active in one of the most promising fields of medicine.A permanent contract with 25 days of paid vacation.A dynamic atmosphere in an internationally minded environment.The benefit of one day per week working remotely to boost flexibility.Other benefits: Mobility plan, competitive company pension plan, support for gym memberships.Regular team-building events such as boot camps, skiing, and much more.-
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