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Open nowPosted 43 days ago

Senior Regulatory Affairs Specialist 100% CDI

Medtronic Europe Sàrl

Where
Tolochenaz, VD, Switzerland
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Your applicationOpen nowSenior Regulatory Affairs Specialist 100% CDIMedtronic Europe Sàrl · Tolochenaz, VD, Switzerland

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  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

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Early applications get read.

13.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.6%3 days
  3. 13.3%7 days
  4. 21.3%14 days
  5. 35.7%30 days
  6. 59.1%60 days
This job: posted 43 days ago

The posting

Responsibilities may include the following and other duties may be assigned.

. Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. . Leads or compiles all materials required in submissions, license renewal and annual registrations. . Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. . Monitors and improves tracking / control systems. . Keeps abreast of regulatory procedures and changes. . May direct interaction with regulatory agencies on defined matters. . Recommends strategies for earliest possible approvals of clinical trials applications.

Required Knowledge and Experience: . Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, Regulatory Affairs, Quality, Clinical, or a related technical discipline. . 4+ years of professional experience with a bachelor's degree, or 2+ years with an advanced degree. . Experience working in a regulated environment (medical device, pharmaceutical, biotechnology, healthcare, manufacturing, clinical, or similar). . Experience interpreting technical information, assessing risks, and making recommendations. . Demonstrated ability to work independently and manage multiple priorities. . Strong written and verbal communication skills. . Experience collaborating with cross-functional teams and influencing stakeholders

Posting text belongs to the employer. Removal requests: contact us.

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