Job Opportunities

JOB TITLE: ASSOCIATE R&D DIRECTOR

WORKING HOURS: MONDAY TO FRIDAY 37.5HRS PER WEEK

CONTRACT TYPE: PERMANENT

SUMMARY:

We are seeking an accomplished Associate R&D Director to operate as the R&D Director’s principal deputy — helping shape the R&D portfolio, ensuring regulatory ready product development, and translating innovation into protected, commercial value.

This role combines senior technical leadership, disciplined project governance, and hands on authorship of key deliverables including 510(k) submissions, patent filings, and peer reviewed publications. The ideal candidate brings strong expertise in antibacterial/antimicrobial technologies, with advanced wound care experience as a strong advantage and demonstrates exceptional project management capability supported by modern digital tools.

You will lead cross functional collaboration, drive predictable execution, and mentor a high performing team while safeguarding quality, speed, and strategic alignment.

This position is ideal for a senior R&D leader who thrives at the intersection of infection control, advanced wound care, regulatory science, and disciplined execution — and who wants to play a pivotal role in shaping the future pipeline while acting as a trusted partner to the R&D Director.

KEY TASKS AND RESPONSIBILITIES:

• Lead and manage R&D programs across the portfolio, ensuring projects meet scope, timeline, cost, and quality expectations.
• Define, run, and continuously strengthen project-management governance, including planning, risk management, decision logs, and reporting.
• Use and champion project-management tools (e.g., Microsoft 365 planner / projects, schedule trackers, resource planning) to improve visibility and execution discipline.
• Own design control and all technical documentation required for regulatory submissions (DHF, DMR inputs, risk management, traceability and/ or equivalent documentation).
• Lead authorship and coordination of FDA 510(k) submissions, including predicate strategy, substantial-equivalence rationale, and integration of verification/validation evidence in partnership with RA.
• Chair design reviews and ensure audit-ready documentation aligned to ISO 13485, 21 CFR 820, CE/MDR, and UKCA expectations.
• Lead IP strategy — identify inventions, draft and review patent specifications and claims, manage invention disclosures, and maintain freedom-to-operate awareness.
• Translate clinical needs and business priorities into clear product requirements, verification/validation plans, and usability/human-factors strategies.
• Provide technical leadership on antibacterial and antimicrobial technologies (e.g., metals, nanoparticles, biocides, barrier systems), ensuring robust testing strategies and defensible claims.Job Opportunities
• Draft and guide scientific manuscripts and conference abstracts for peer-review publication while protecting intellectual property.
• Manage cross-functional collaboration with QA/RA, Operations, Quality, and Commercial teams to de-risk projects and accelerate time-to-market.
• Drive cross-group collaboration across internal teams and sister functions, ensuring alignment across R&D, Operations, Quality, Commercial, and Finance.
• Build and manage external partnerships (suppliers, CROs, academic collaborators, CROs, and strategic partners) to accelerate development and de-risk technical challenges.
• Engage directly with customers and prospective clients; bring a commercially savvy perspective to discussions on requirements, feasibility, and value, liaising closely with the Business Development and Commercial Functions.
• Plan and manage the R&D budget, track variances, and prepare concise monthly progress and financial reports for the R&D Director.
• Support portfolio prioritisation, risk reviews, and executive reporting; act as primary delegate for the R&D Director when required.
• Mentor and develop senior scientists and engineers; foster a high-performance culture built on accountability, curiosity, and collaboration.

KEY SKILLS/ABILITIES:

Essential skills:

• Degree in chemistry, materials science, biomedical engineering, or related discipline (MSc/PhD preferred).
• Significant experience leading multi-disciplinary R&D programs with full lifecycle design-control responsibility. Minimum 10 years’ experience in senior roles.
• Proven, advanced project-management capability — planning, risk management, stakeholder communication, and stage-gate governance.
• High proficiency with project-management tools (e.g., MS Project, Smartsheet, Jira/Asana, portfolio dashboards) and data-driven reporting.
• Hands-on authorship of regulatory documentation — preferably direct experience preparing and assembling 510(k) submissions.
• Track record working with intellectual property, including drafting contributions to patent applications and claims.
• Experience with antibacterial / antimicrobial technologies in medical devices, materials, coatings, or related life-science applications.
• Excellent written and verbal communication — capable of producing clear technical reports, dossiers, and scientific papers.
• Strong leadership presence — able to influence, challenge constructively, and make evidence-based recommendations.

Highly desirable skills:

• Direct experience with advanced wound-care, acute wound care, haemostatic devices.
• Prior interaction with FDA and/or Notified Bodies.
• Publication history in peer-review journals.
• Practical involvement in EU MDR, CE-marking.
• Formal project-management qualification (Prince2/PMI/Agile) or equivalent experience.Job Opportunities

Qualified and interested candidates should send a copy of their CV and covering letter detailing their suitability for the role to recruitment@sfm-limited.com