Senior Regulatory Specialist

7 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $160,000
Job Description:

As a Senior Regulatory Specialist, you will lead regulatory assessments and develop strategic plans for products and services. You will work closely with cross-functional teams to ensure compliance and deliver optimal regulatory strategies.

You will be responsible for defining regulatory approaches for Incubation & Growth (I&G) products and services. This includes authoring and reviewing global regulatory submissions, interpreting device-specific requirements, and aligning with regional RA teams.

Key responsibilities include performing significance evaluations, preparing documentation updates, collaborating with Engineering and Quality, and representing RA in cross-functional design teams. You will also engage early in project scoping and risk management activities to shape regulatory deliverables and timelines.

Key Responsibilities:
  1. Define regulatory strategies for I&G products and services.
  2. Author and review global regulatory submissions.
  3. Interpret device-specific requirements.
  4. Align with Regional RA teams.
  5. Perform significance evaluations.
  6. Prepare documentation updates.
  7. Collaborate with Engineering and Quality.
  8. Represent RA in cross-functional design teams.
Qualifications and Skills:

To be successful in this role, you will need strong regulatory knowledge, excellent communication skills, and the ability to collaborate effectively with cross-functional teams.

Key qualifications and skills include:

  1. Regulatory knowledge and experience.
  2. Excellent written and verbal communication skills.
  3. Ability to collaborate effectively with cross-functional teams.
  4. Strong analytical and problem-solving skills.
  5. Ability to prioritize tasks and manage multiple projects simultaneously.
Benefits:

This is a unique opportunity to join our team as a Senior Regulatory Specialist. You will have the chance to work on exciting projects, develop your skills and knowledge, and make a real impact in the industry.

As a valued member of our team, you can expect:

  • A competitive salary and benefits package.
  • The opportunity to work on challenging and rewarding projects.
  • A collaborative and supportive work environment.
  • Professional development opportunities.
  • The chance to make a real impact in the industry.
How to Apply:

If you are a motivated and experienced regulatory professional looking for a new challenge, we would love to hear from you. Please submit your application, including your resume and a cover letter, to apply for this exciting opportunity.

We look forward to hearing from you and exploring how you can contribute to our team's success.

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