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Senior Regulatory Affairs Manager

Posted Dec 11, 2019
Project ID: PHILJP00021052
Eindhoven , Noord Brabant
11 months
(Feb 1, 2020 - Jan 1, 2021)
40 hrs/week
Payrate range
52 - 78 €/hr
Senior Regulatory Affairs Manager

The Senior Regulatory Manager is part of the Regulatory Affairs Team of the Innovation Site Eindhoven (ISE). In this position the Sr. Manager will be responsible for leading High Profile Medical Device development projects for the Beauty business who is part of Personal Care. The Sr. Regulatory manager is a strategic partner for the business groups. The activities will focus on the hair removal devices called Lumea.
a decision maker, an influencer and gatekeeper to support the business development team to create safe and effective products for our customers.

You are responsible for
Activties include;
Regulatory Ownership of the Medical Devices, being the primary point of contact for the development teams.
Involved early in Advanced Development Projects and Value Proposition Creation
Involved in Clinical Claim Development
Create Assessments of Medical Device Classifications for applicable Markets globally
Create Regulatory Strategy Plan for new Lumea Hair Reduction device projects
Review Product Compliance Plans as created by Safety & Compliance Managers
Review Product Labeling Plan
Review Clinical Study Plan and Reports
Create Regulatory Medical Device Submission Packages for markets like EU, U.S., Brazil, China.

You are a part of
A dynamic and divers, team of highly specialized professionals with a common goal.

To succeed in this role, you should have the following skills and experience
10+ years of experience in medical device regulations, in a commercial environment
Global medical device regulation knowledge for EU (MDD and EU-MDR), United States (FDA), Brazil (Anvisa)
Proven successful track record in regulatory submissions for medical devices
Knowledge of Clinical Study setup,
execution and reporting.
Familiar with MDSAP and ISO 13485
Knowledgeable on Product Risk Assessment strategies
Strong Senior Personality being able to take position and guide a project team
Knowledge of different standards for household and medical devices (e.g. electrical standards)
Knowledge on Software Development

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