Develops new strategic approaches for regional / country-specific submissions to achieve smoother and faster regulatory approvals, with the goal of significantly earlier and greater commercial success of ADCs products and services in the region.
Works externally with regulatory authorities, notified bodies, advocacy groups (for example, MedTech Europe and AdvaMed in the US), UDI issuing agencies (for example, GS1) and others, as needed, to identify, understand and determine the applicability of emerging MDR/IVDR requirements.
Directs and oversees the development and implementation of regulatory solutions and strategies for new product/features/services registrations. This may include innovative and/or untested solutions and strategies.
Manages a team of 5-6 RA employees and RA contractors, including managers with country responsibility.
Works internally with regional Regulatory Affairs managers, Premarket Regulatory Affairs, Quality, Product Life Cycle Management, Supply Chain, regional and local commercial personnel (Sales, Marketing and Customer Service), Engineering Services, Packaging & Labeling, and Master Data to develop the plans necessary to ensure compliance with applicable MDR/ IVDR requirements.
Strategic partner to regional Americas and European leadership teams in all RA aspects of commercialization, marketing, and overall business development
Develops close working relationship with Program Development and relevant stakeholders to facilitate seamless regulatory support for all ongoing and future development projects.
Represents ADC in interactions with the regulators or distributors in all aspects of registrations.
Engages and develops a rapport with key stakeholders to drive improvement in ADC's relationship with the regulators.
As a representative of ADC, participates with trade associations, distributors and/or regulators to engage in policy development on issues that have the potential to impact diabetes care.
Facilitates global product registrations by ensuring applicable design and development documentation is made available for submission to local regulators.
Keeps abreast of changes in the regulatory environment and ensures that these are strategically assessed for the potential to impact ADC.
Improve product clearance/approval timing with the local regulators via direct engagement with the reviewing branches to proactively address issues and drive resolution in a timely manner. Drive increased trust at the agencies in ADC and our products.
Improve the relationship with internal stakeholders to ensure timely regulatory input into development programs.
Provide regulatory guidance and strategy to address new spaces/product concepts. Where applicable, engage with relevant regulatory bodies and trade associations to help develop and shape policy around potential cutting edge products or new spaces not previously regulated.
Provide leadership to the Regional RA team and drive improvements in team dynamic and operations.
The ideal Candidate:
Bachelor degree in science or technical field required
Master's degree preferred
Regulatory experience in a global environment for 12-15+ years in the medical device industry with demonstrated interactions with health authorities
Excellent communication skills, verbal and written