Director, Quality and Regulatory

1 week ago


Butterworth, Penang, Malaysia Haemonetics Software Solutions Full time

Haemonetics is committed to the protection of personal data in accordance with applicable laws and regulations.

The editor and data controller is Haemonetics Corporation, 125 Summer Street, Boston, Massachusetts, 02110 U.S.A. The global Data Privacy Officer of Haemonetics can be reached at this address.

Director, Quality and Regulatory page is loaded

Director, Quality and Regulatory Apply locations Batu Kawan, MY time type Full time posted on Posted 7 Days Ago job requisition id R8544

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

Job Details

Office Based - Penang, Malaysia

Full-Time position

Ready to Think Big and Take Action?

At Haemonetics, we develop innovative medical technology products and services that improve the quality, effectiveness and efficiency of care. We are building a collaborative, performance-driven culture that attracts and develops the best talent.

What are you going to do in this role?

As the leader of regional Regulatory Affairs (RA) and Quality Assurance (QA), you'll spearhead a team of 9 experienced professionals dedicated to ensuring the quality and compliance of our products throughout the APAC region along with our Manufacturing site in Penang. This pivotal role offers you the opportunity to oversee the distribution of various medical devices, ensuring they meet rigorous standards.

You'll be the face of quality and regulatory matters within our organization, fostering trust with both internal stakeholders and external regulators and customers.

Moreover, you'll represent our company in crucial regulatory discussions, assessments, and negotiations, allowing you to influence the direction of product licensing and quality initiatives.

Collaborating with other regional heads of Quality and Regulatory in Europe and the Americas, you'll play a vital role in shaping product quality and regulatory compliance on a global scale.

In this role, you'll have substantial autonomy to lead your team and make decisions independently. With minimal oversight, you'll be entrusted to drive initiatives according to your expertise.

What do you need to succeed in this role:

In this pivotal role as Director of Quality and Regulatory at Haemonetics, we seek a seasoned professional who possesses a unique blend of technical expertise, leadership acumen, and strategic vision.

Your leadership style fosters a culture of excellence, empowering your team to deliver exceptional results. With over 7 years of people management experience, you've honed your skills in mentorship and development, ensuring that your team meets and exceeds performance expectations.

With a Bachelor's Degree in Quality, Engineering, Science, or a related discipline, coupled with at least 5 years of progressive experience in both regulatory affairs and quality assurance roles within the market, you bring a wealth of knowledge and insights to the table.

Recruitment process

Our recruitment process involves an initial interview with Morgane, our Talent Acquisition specialist, followed by an interview with the current Director. Finally, there will be a panel interview with the direct supervisor and other regional heads to ensure alignment with our organizational goals and culture.

If this sounds like you and you're eager to join a dynamic and teamwork-oriented setting, apply now

EEO Policy Statement

Throughout our history, we have earned a solid reputation for product innovation, technical expertise, and operational excellence. Today, our products, internal research and development, marketing partnerships, and product acquisitions reflect our unwavering commitment to provide safe and available blood for patient transfusions and for use in pharmaceuticals.We rely on our talented global workforce to help us achieve our mission of providing innovative medical devices that advance the safety, quality, and availability of the world's blood supply. To achieve our business goals and objectives, we are committed to attracting and retaining the best and brightest talent while offering a challenging, dynamic, and exciting work environment that offers professional growth and development.

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