Senior R&D Program Manager

• More than 15 years of experience as an R&D Project Manager in the medical device and IVD industry, with strong expertise in Regulatory Affairs, Quality, and global program leadership

• Has led multi-project environments with up to 11 parallel programs, coordinating large, cross-functional teams across Europe, the US, Asia, and LATAM

• Experience includes driving design control and process improvement initiatives across the product lifecycle, achieving significant reductions in lead times and process costs of up to 70%

• In addition, has successfully led critical programs in regulated environments, including FDA 510(k) submissions, global market access initiatives, and turnaround/task-force assignments, ensuring delivery under high time and cost pressure

• Already placed via K-Recruiting with excellent client feedback (2022-2024)

Multi-Program Lead: R&D, Market Access and RA — Global IVD Market Leader

Leader for up to 11 concurrent projects. Initiated and led two major process improvement projects including a new design control process and a late-point product configuration model shortening lead times significantly and cutting process cost by 40-70% depending on product group.

Situation & Mandate

• Company quickly needed support for various R&D and Global market access programs which were operating without leadership

• Major regulatory compliance project: new South Korean regulatory requirements impacting the entire portfolio in that market

• Stepped into interim marketing/product management role when the position became vacant — maintaining business case quality and continuity

Actions

• Led up to 11 teams for R&D, Global market access and regulatory compliance programs

• Total team size 90+ headcounts located in Europe, US, Asia, and LATAM; up to 7 report lines

• Led 7 concurrent IVD product developments (assays and accompanying products)

• Led various Global market access programs across LATAM, North America and Asia-Pacific

Results

• All 7 product development programs managed on schedule across the engagement period

• South Korean regulatory compliance project delivered within tight timelines, securing the entire market portfolio

• New market access achieved across multiple regions on three continents

• Initiated and led two major process improvement programs: new design control process and late-point product configuration model

• Process cost reduction of 40–70% per product group; lead times significantly shortened

Project Rescue & FDA 510(k) Program Lead — Medical Device Company

Took over a critical project for a medical device essential for entire US business facing market loss. The company had placed a non-cleared life-supporting device component on the US market; the FDA had set a hard deadline and the project was already 13 months behind schedule. Reorganized the entire project, recovered 11 months of delay, reduced cost by ~15% and enabled successful regulatory submission.

Situation & Mandate

• Significant regulatory and commercial risk: Component for life-supporting device placed on US market without FDA clearance

• 13-month program delay at intake; Steering Committee demanded a ‘radical approach’

• Cross-functional team across Germany and four US locations with organizational misalignment and unclear ownership

• Entire US business dependent on successful and timely submission

Actions

• Complete project reorganization: new governance, clear responsibilities, accelerated critical path

• Led teams across Germany and four US sites establishing alignment and shared accountability

• Scope expanded mid-engagement: temporarily managed 2 additional projects; coached incoming project leaders over 6 months

• Presented improvement observations and systemic gap analysis directly to the managing board

Results

• 11 months of delay recovered

• 15% project cost reduction

• 510(k) submission successfully filed — US market risk eliminated

• Strategic improvements and process guidelines adopted as company-wide templates for future projects

• Multiple systemic gaps addressed with lasting impact beyond the immediate project

Interim Global Operations Lead — Pharma-Pharma Merger Integration

Joined a pharma merger integration at 48 hours’ notice to lead Global Operations reporting to the Head of New Product & Strategy Implementation and serving as a member of the Steering Board. Set the direction for multiple programs, defined manufacturing strategies, and conducted make-or-buy assessments well beyond $100M.

Situation & Mandate

• Major pharma-pharma merger requiring urgent operational leadership across Germany, Austria and the US

• Multiple programs in flight with no clear ownership or strategic direction

• Cross-functional complexity spanning Scientific, Manufacturing, CMO Management, Supply Chain, Quality, Regulatory, Legal/IP and Operations budget

• Several programs already behind schedule; financial control and cost assessment inadequate

Actions

• Set strategic direction for multiple program within the first week, including make-or-buy assessments well beyond $100M

• Line manager (direct report lines) for various functions such as PSTO (Process-, Science, Technology), Manufacturing, CMO Management/Supply Chain, Quality, Regulatory, Legal/IP

• Part of Steering Committee: direct report from project managers; strategic alignment with other depts. such as Clinical/Medical/Marketing etc., Prioritization of programs

• Defined manufacturing strategies for key products across the merged portfolio

• Coordinated cross-functional sub-teams across DE/AT/US in a high-pressure cross-cultural environment

• Provided Steering Board with clear program status, risk landscape and acceleration path for delayed projects

• Established improved financial control and cost assessment frameworks across the program portfolio

Results

• $150M+ in strategic decisions defined within first week

• Short- and mid-term program strategy established across the combined organization

• Acceleration path defined for delayed projects; financial control and cost visibility significantly improved

• Foundation set for post-merger operational integration with clear governance and program ownership

Turnaround & Task Force Lead — Global IVD Market Leader Deployed as external turnaround lead when an internal task force had already failed to resolve critical quality, production and audit issues with the key OEM partner for a new flagship diagnostic instrument. Resolved all major issues within 3.5 months, securing product launch and preventing a potential 2- year delay worth $100+M.

Situation & Mandate

• OEM partner failing to meet quality and quantity targets; large backlog of unresolved audit findings

• Financial exposure at intake: ~€200K/day in ongoing losses

• Worst-case scenario: full project restart with a new partner resulting in ~2 years extension to market launch and €100M+ in total impact

• Internal task force had already attempted and failed; external escalation was the last resort

• Need to provide alignment and solution for conflicting interests between client and OEM

Actions

• Rapid root-cause analysis across quality, production, documentation and traceability processes

• Structured change management directly with OEM management board — re-establishing accountability and governance

• Targeted corrective actions across all open findings with clear ownership and milestone tracking

• Internal stakeholder alignment at client on realistic timelines and escalation protocols

Results — delivered within 3.5 months

• Production meeting quality and quantity targets: critical bottleneck resolved

• Supplier audit-ready: all major findings closed or on documented remediation path

• Product launch readiness secured for flagship cash-cow product

• €200K/day loss exposure eliminated; potential 2-year delay and €100M+ impact averted