Associate R&D Director in Leicester

Location: Coventry, West Midlands, CV3 2RQ

Salary: Competitive, DOE

Contract: Permanent, Full time

Benefits: Competitive salary, Contributory pension scheme, Life cover, Incapacity benefits, Cash Back Medical Scheme

About the Company:

We are an innovative medical devices manufacturer of advanced wound care products, including combination products, from gelling fibres and fabrics. We deliver innovative, cost effective and quality products and solutions for the advanced wound care industry helping to improve patient care and wellbeing.

About the Role:

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.

Duties to include:

• 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.
• 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.

Important Information:

Due to the number of applications we receive, we will only contact those candidates that we want to take forward to interview; if you do not hear from us within 4 weeks, please assume that your application has been unsuccessful on this occasion.

If you have the skills and experience we require for this role and are looking for a new challenge, please click on APPLY Today and forward an up-to-date CV and cover letter, explaining why you are a good fit for this role.

No Agencies please!