By John Baker

Through our experience, we have found the biggest challenge in recruiting and placing senior level Regulatory Affairs and Quality Assurance Executives, is finding the right balance of technical knowledge, communication skills and leadership qualities.

Often times, RA/QA leaders are not groomed or mentored to build the same kind of leadership skills as executives in many other functional areas. Typically the paths of CEO’s and RA/QA leaders are divergent; creating an experience and perspective gap between the two parties.

We have seen that the industry’s top RA/QA talent have developed strong communication skills and business savvy that allow them to educate other senior executives, narrow the gap in perspectives and drive decision making. RA/QA executives must acquire business acumen along their career and learn how to align global health authority requirements with the goals of the company. This can be daunting at times, due to the pressures of the business requirements and of those agencies.

Clearly, it is beholden upon RA/QA leaders to appropriately minimize risk while ensuring compliance and avoiding unfavorable scenarios. Ultimately, everyone in a company must align with the CEO & Board’s vision; RA/QA is no different. The top 10% of RA/QA executives are trusted advisers, have a balanced risk-profile, demonstrate business maturity, and are great cross-functional communicators.

What is key to the success of any company is their ability to streamline the submission and approval process and eventual commercialization and revenue generation of those new products. Having experienced regulatory/quality personnel with long standing relationships with the FDA and appropriate agencies is critical to that success. So when issues arise an experienced RA/QA executive can find their way through the maze and communicate with the FDA to resolve those issues.

Furthermore, that experienced executive possessing the aforementioned business acumen will be able to educate the senior leadership team when things may slow down or reach an impasse avoiding key concerns internally with people and processes. Being able to build trust and credibility internally with their company’s executive team is critical. Avoiding mistakes will do a great deal to speed the process of approval with the FDA. In addition experienced regulatory/quality executives who have long standing relationships with the agencies are in a much better position to leverage those relationships leading to expedited review times.

Additionally having RA/QA Executives with global experience is vital to success. The Global Harmonization Task Force on Medical Device was put in place to help with the uniqueness of needs in differing regions and hence leadership qualifications to impact those regions. RA/QA Executives must possess a well-rounded technical background along with an understanding of cultural differences and be able to lead in those environments. Being able to work through the uniqueness of medical devices in different regions with different legislative issues governing approvals, requires an Executive with diverse leadership qualities and skills to understand and work within multiple cultures bridging the gaps as necessary.

So it comes as no surprise that there is a demand for talent for those with the aforementioned skills. Where will they come from and what educational backgrounds will be required? RA/QA specialists with the most education will experience the most opportunity and the highest pay.

Companies are looking for the most experienced and talented in this field. Currently clients have promoted from within. Often times this has been from other functional areas like R&D. As demand increases, as it has, those from within who have bachelor’s degrees will be competing with new talent that have focused on regulatory and quality and who may have scientific and master’s degrees in related fields. Recruiters especially look for candidates with masters or doctoral degrees in science, but also regularly hire people with medical and law backgrounds that demonstrate related skills and experience.

As demand increases for top talent, those who traditionally have found their way from other functional areas with less education will have a harder time competing in this area.

John Baker is an executive vice president and managing director of DHR International’s Global Life Science Practice group.