Senior Regulatory Specialist - Passo Fundo - beBeeMedical

Título do emprego: Regulatory Affairs Specialist

Descrição

Regulatory Affairs Professional

We are seeking a highly skilled Regulatory Affairs professional to lead our team in the medical devices industry. This role involves ensuring compliance with European regulations and providing expert support in CE Marking processes and conformity assessments.

About the Role:

• This position is responsible for leading regulatory affairs activities, including managing regulatory changes, assessing their impact on product portfolios, and defining regulatory strategies.

Your Key Responsibilities:

• (As An Expert In Medical Device Classification), you will ensure correct application of classification rules for Class IIa and IIb medical devices.
  
• You will coordinate the preparation, review, and maintenance of technical documentation (EU MDR Annexes II and III).


• In your capacity as an expert in medical device classification With A Focus On class iiA And iiB medical Devices Ensure Correct Application Of Classification Rules
  
  Provide Expert Support In Ce Marking Processes And Conformity Assessments Including Direct Interaction With Notified Bodies As part Of Our Team You Will Be Involved Across Multiple Industries In Complex Regulatory Contexts We Are Looking For Someone Who Is Able To Work Independently But Also Collaborate Effectively Within A Global Team That Covers Regions Such As Europe Asia And North America The Perfect Candidate Has Strong Analytical Decision Making Prioritization Skills Leadership Autonomy Stakeholder Management Skills International Environments Some Knowledge About Gdpmdr Regulations Would Be Beneficial Alongside Academic Backgrounds Pharmaceutical Chemistry Biomedical Engineering Pharmacy Health Sciences Or Related Fields Advanced Fluency English Both Spoken Written Required If Interested Please Contact Us Using this Link .