Regulatory Affairs Manager Job at Nemera (Lyon)

Job Description

Within Nemera’s headquarters, you will lead the Regulatory & Compliance activities for a diverse portfolio of ENTD (Ear, Nose, Throat & Dermal), Ophthalmic and Inhalation medical devices and combination products, covering different regulatory pathways and risk profiles. You will report to the Global Regulatory & Compliance Manager, and work in close collaboration with development, quality, industrialisation, operations and commercial teams, as well as with customers and external stakeholders. You will be involved throughout the full product lifecycle, from early development phases to post-market activities, defining regulatory strategies, supporting quality management plans and contributing to QMS development and continuous improvement.

Job Responsibility

Lead the Regulatory & Compliance activities for a diverse portfolio of ENTD (Ear, Nose, Throat & Dermal), Ophthalmic and Inhalation medical devices and combination products
Manage the Regulatory & Compliance team of the Business Units ENTD and Ophthalmic and Inhalation Products
In charge of the resources assessment needed for regulatory and normative activities under your ownership and product platform
Collaborate in building the product regulatory strategy and regulatory impact assessment of changes
Collaborate with development teams and production site(s) to ensure correct implementation of regulatory and normative activities
Support and guide our customers in their notification procedure particularly in EU, US and Canada
Contribute to the continuous improvement processes
Support the Regulatory Team in the preparation, verification and approval, of regulatory documents for submission
Contribute and assist when necessary to internal or external audits and propose corrective and preventive actions
Collect and interpret elements of the monitored standards, inform product or process managers for the changes, analyze and synthesize gaps
Support development teams during product-specific normative interactions with external stakeholders
May participate in standardization committees and external expert groups
Conduct in-depth analyzes of proposed product changes, assessing their impact, evaluating the normative compliance and proposing corrective measures if necessary
Collaborate closely with other BUs

Requirements

Master’s degree or higher in life sciences or sciences (Pharmacist, Master in Regulatory Affairs)
At least 8 years of professional experience (Combination Products)
Experience in managing and developing teams
Background in pharmaceutical or biomedical industry in multicultural and interdisciplinary environment
Experience in leading Regulatory & Compliance projects in transversal projects
Experience in quality management system (ISO13485) and Risk Management (ISO 14971)
Advanced knowledge and experience in MDR 2017/745, awareness of IEC 62304 and ISO 10993
Good English speaking and written
International committee experience

Nice to have

Effective interpersonal skills with ability to work in a team or independently
Ability to multi-task and manage priorities with effective organizational and time management skills
Demonstrated flexibility and adaptability
Highly motivated with a proactive approach to learning and problem solving
Confident communicator, both verbally and in writing, and in presenting information concisely to others in a group or one to one setting
Analytical and synthetical skills

What we offer

Possibility of working from home 2 days per week
Varied jobs in an international group
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Regulatory Affairs Manager

Job Description

Job Responsibility

Requirements

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