QAra Specialist

Position Summary and Overview of QARA Specialist role:
6 Month casual contract

This is a professional position with responsibilities for elements of the site regulatory and Quality obligations. May include specialized responsibilities in identification and implementation via the regulatory intelligence process of new or revised guidance and regulations, specifically IVDR; communications with regulatory bodies; regulatory compliance assessments, post-market surveillance; regulatory core team member for new product development and device change processes including accountability for strategy and execution of submissions.

Major Responsibilities
- Responsible for planning, organizing and conducting duties related to the site’s regulatory and quality obligations including, but not limited to:

- Implementation of new regulations:

- Identify and assess new or updated regulations for impact on the business
- Participate and contribute to LBS or Danaher councils for regulatory intelligence and compliance.
- understanding of global regulatory strategy for new products and significant product changes:

- Product change reporting and compliance assessments including review and approval of labeling, advertising and promotional material for compliance to applicable regulations.
- Representation of Regulatory Affairs and Quality in external audits including FDA pre-approval inspections.
- Utilize knowledge and experience to identify and solve problems and improve processes within the regulatory area utilizing the Danaher Business System (DBS) tools.
- Establish and maintain strong relationships with internal and external stakeholders.
- Maintain working knowledge of relevant regulations and requirements that affect the business.
- Other duties as assigned by management.

Required Skills/Experience/Education
- Bachelor’s degree preferably in science, medical or engineering.
- Minimum 3 years Regulatory Affairs or Quality management experience in medical devices required, IVD instruments experience highly desirable.
- Proven cross-site, cross-functional business partnering.
- Instrument Release
- Customer complaints

Competencies
- Attention to detail.
- Ability to identify and assess patient and user risk.
- Critical thinking.
- Strong organizational skills. Ability to multitask.
- Strong communication skills (verbal/written/presentation/relationship building) with ability to work collaboratively with cross-functional project teams and regulators.
- High level of initiative, self-motivation and energy.
- Ability to explain difficult or sensitive information. Works to build consensus.
- High level of integrity. Consistently uses sound judgment. Operates with transparency and is trusted. Demonstrates humility and self-awareness.

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful **Danaher Business System** tools and the stability of a tested organization.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

If you’ve ever wondered what’s within you, there’s no better time to find out.