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Senior Regulatory Product Strategy

2 weeks ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $160,000 - $200,000
Job Description

At the forefront of health technology innovation, our team plays a pivotal role in ensuring timely and compliant access to global markets. With a presence spanning over 140 countries, we deliver safe and effective innovations that significantly improve quality of life.

This is an exceptional opportunity for a strategic leader to oversee regulatory execution for NPI and PLE projects, guiding the development of design input requirements, verification strategies, and risk documentation that meet global regulatory expectations.

Key Responsibilities:
  • Lead RA strategy and delivery for NPI projects owned by Sydney.
  • PLE projects owned by the Sydney and Singapore legal manufacturer.
  • Define regulatory pathways and ensure submission planning aligns with market access timelines and business needs.
  • Guide the development of design input requirements, verification strategies, and risk documentation that meet global regulatory expectations.
  • Escalate risks, resource constraints, or submission delays proactively and constructively.

In this leadership role, you will be accountable for team performance, resource allocation, regulatory input into cross-functional design activities, and timely submissions across markets.

Required Skills and Qualifications

To succeed in this position, you will need:

  • Bachelor's degree (or higher) in biomedical engineering, life sciences, regulatory affairs, or a related discipline.
  • 6+ years in Regulatory Affairs, with 2+ years in a leadership or mentoring capacity.
  • Proven experience supporting device submissions.
  • Excellent knowledge of ISO 13485, ISO 14971, 21 CFR 820, and other applicable standards.
  • Experience working on design and development teams under design control processes.
  • Strong organizational and time management skills.
  • Clear, structured communicator with experience influencing cross-functional partners and regulatory authorities.
Benefits
  • A dynamic work environment that fosters growth, collaboration, and innovation.
  • The opportunity to make a meaningful impact on the lives of millions through healthcare innovation.
  • A competitive compensation package that recognizes your expertise and value.
  • Ongoing professional development opportunities to enhance your skills and stay at the forefront of regulatory affairs.
Others
  • A strong sense of purpose and fulfillment from contributing to a company that prioritizes patient-centered care and innovative solutions.
  • The chance to work with a talented and diverse team of professionals who share your passion for regulatory excellence.
  • A culture that values open communication, empathy, and mutual respect.