Job Title: Executive Vice President Regulatory Affairs
A Company that provides world-class genetics research solutions to leading clinical and academic research institutions. The Company’s range of microarray, FISH and next generation sequencing products deliver high-quality, high-throughput genetic analysis, enabling accurate identification of the causative variation underlying genetic disease.
Significant Regulatory Affairs experience in molecular diagnostics or medical devices. Demonstrable experience of achieving 510(k) or PMA clearances through FDA. Demonstrable experience of achieving CE IVD accreditation. Excellent man-management skills. Strong project management skills.
The EVP Regulatory Affairs will be the Company’s most senior regulatory affairs executive with responsibility for achieving regulatory approval of products, maintaining compliance and ensuring a productive working relationship with global regulatory authorities. The role will have responsibility for regulatory strategic input and implementation to drive the continued growth in; product development and geographic footprint, in line with the Group’s overall business objectives.
Sally Hope, CEO
PiR is a specialist recruitment company, established for over a decade, focused exclusively on identifying senior talent who deliver strategically and operationally to international life sciences organisations.
The relevance and depth of PiR’s expertise is reflected in the team’s combined life science recruitment experience of over 40 years; across key business functions at leadership and expert level. Our exclusive focus on, and network in, the sector ensures our solutions are aligned and relevant to client companies, reflecting our inherent understanding of the life science industry.
PiR’s client services include:
• Executive Search
• Interim Management Services
• Talent Mapping
PiR’s team is aligned to provide a depth of expertise across key business segments:
• Early stage, investor backed and SME organisations, as well as mid-capped specialist companies. These include advanced and novel therapies (cell, gene, and RNAbased), orphan drugs and innovative medical technology
• Building senior teams for newly funded and growing organisations
• Director, leadership and expert level; Medical/Medical Affairs, Clinical, Regulatory, Manufacturing Operations (including Quality and Supply Chain) and Commercial (HEOR, Pricing & Reimbursement, Market Access, product management)
• Board level appointments (CEO, CBO, COO, CSO, CMO, Chair, NED)
To learn more about PiR, please contact Sally Hope, CEO at firstname.lastname@example.org. Tel: + 44 (0) 1480 499580