Senior Director, RA

Radiometer

Brønshøj, Denmark

As our Senior Director of Global Regulatory Affairs, you will play a critical role in ensuring that our company is in compliance with all relevant regulations and standards. You will lead a team of 50 regulatory professionals and work closely with cross-functional teams to develop and execute regulatory strategies that support our business objectives. You will be accountable for the performance and results of the RA organization, including compliance, audit preparation and completeness, and growth initiatives such as registrations and submissions.

This position is part of Global RA/QA located in Denmark and it will be a hybrid setup as we have a flexible working environment with the opportunity to regularly working from home. You will be a part of our Senior RA/QA Leadership Team and report to the VP of Global RA/QA.

At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. To support this vision, we are seeking a highly experienced regulatory affairs professional who can lead our organization through the ever-changing regulatory landscape, while driving cross-functional collaboration and continuous improvement, and maintaining the highest levels of compliance. If you are passionate about making a difference in patients' lives through innovative and compliant products, you might be the right candidate for this position?

In this role, you will have the opportunity to:

Develop and implement regulatory strategies for successful product approvals;
Provide strategic guidance to cross-functional teams on regulatory requirements and risks;
Ensure compliance with relevant regulations and standards by developing and maintaining policies and procedures;
Identify and communicate potential regulatory risks to senior leadership;
Build and maintain strong relationships with key stakeholders, including regulatory agencies, industry associations, and other external partners, to partner for impact;
Manage and develop a high-performing team of regulatory professionals;
Prioritize the wellbeing, talent, and organizational development of the RA department;
Lead through Danaher Business System (DBS) tools to drive continuous improvement.

The essential requirements of the job include:

Demonstrated success in leading teams and driving change in a global and dynamic environment;
10-15 years of professional experience in medical device regulatory affairs, including leadership of QA/RA or regulatory affairs for a complex business unit;
In-depth knowledge of FDA regulations, guidelines, and submissions. Stay updated on changes to regulations, standards, and guidelines worldwide, as well as industry trends and best practices;
Strong commitment to quality and compliance, with excellent organizational skills;
High level of initiative, self-motivation, and customer focus with a visionary approach;
Reliable and responsive in all aspects of work;
Master's degree or PhD in a science, engineering, medical, or technical field;
Proven track record of successful regulatory strategies, clearances, and approvals, including experience with international audits and negotiations with regulators.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job