Director of Compliance and Regulatory Affairs

5 days ago


Gothenburg, Västra Götaland, Sweden Cochlear Full time
Role Summary:

As the Director of Regulatory Affairs, you will play a pivotal role in leading our Regulatory team in Gothenburg and ensuring compliance and timely approvals for acoustics products worldwide. This is an excellent opportunity to work with a global leader in implantable hearing solutions and make a significant impact on a global scale.

The ideal candidate will have extensive experience in regulatory affairs, particularly in medical devices, and a proven track record of developing and executing global regulatory strategies. They will mentor and guide the team to provide critical regulatory insights for Product Innovation Process (PIP) and negotiate with external regulatory bodies and communicate effectively with stakeholders.

Key Accountabilities:

  1. Regulatory Strategy:
    • Develop and execute global regulatory strategies.
    • Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
  2. Regulatory Compliance:
    • Ensure compliance with relevant regulatory requirements and standards.
    • Develop and implement processes to manage regulatory submissions and commitments.
  3. Team Management:
    • Mentor and guide the team to provide critical regulatory insights for Product Innovation Process (PIP).
    • Provide feedback and coaching to foster growth and success.

Requirements:

  1. Essential:
    • Bachelor's degree in a related field with extensive experience in Regulatory Affairs.
    • Knowledge of at least two medical device jurisdictions.
    • Proven experience in healthcare, regulatory affairs, and medical devices.
    • Expertise in financial mechanisms.
    • Demonstrated ability to lead teams and collaborate.
    • Exceptional attention to detail and proficiency in English.
  2. Desirable:
    • Master's degree in a related field.
    • Strong negotiation skills for optimal commercial outcomes.
    • RAPs certification.

If you're passionate about making a difference in people's lives and have the skills and expertise we're looking for, please submit your application.



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