A Day in the Life
At Medtronic you can begin a lifelong career of exploration and innovation while championing healthcare access and equity for all. You will lead with purpose, breaking down barriers to innovation in a more connected compassionate world.
Medtronic is hiring a Regulatory Affairs Specialist responsible for operating as an established productive individual contributor who works independently on moderately complex projects. You will set objectives for your own work to align with broader project goals and actively contribute to key milestones.
Responsibilities
- Direct or perform coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits and inspections.
- Lead and compile all materials required in submissions, license renewal and annual registrations.
- Recommend changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance.
- Monitor and improve tracking as well as control systems.
- Keep abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.
- Recommend strategies for earliest possible approvals of clinical trials applications.
Required Knowledge and Experience
- Experience in medical device regulatory including UK MHRA submissions and CE/UKCA marking.
- Strong knowledge of EU MDR, ISO 13485 and ISO 14971 risk management principles.
- Proven experience preparing regulatory dossiers, technical files and product registrations.
- Ability to interact effectively with Notified Bodies and regulatory authorities including supporting audits and FSCAs.
- Excellent technical writing skills with the ability to interpret and apply regulatory guidance.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.
Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package. This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP).
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our mission to alleviate pain, restore health and extend life unites a global team of 95,000 passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives and guts to engineer the extraordinary.
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