Research and Development Project Manager

Advanced Medical Solutions; Plymouth; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading medical device company in the UK is looking for an R&D Project Manager to oversee complex product development projects. The successful candidate will have strong project management skills and an understanding of medical device compliance, including GMP and ISO standards. Responsibilities include leading cross-functional teams, managing project risks, and ensuring adherence to regulatory requirements. This role offers the opportunity to work in a collaborative environment focused on innovation and product quality.

Qualifications

• In-depth knowledge of project work and adherence to deadlines using Agile and waterfall methodologies.
• Proficient in Medical Device product development procedures and compliance with ISO standards.
• Understanding of regulatory submission types such as CE-marking and FDA pathways.

Responsibilities

• Planning, controlling, and monitoring R&D product development projects.
• Leading cross-functional teams to achieve project goals.
• Overseeing design control activities and risk management compliance.

Skills

Project Management

Cross-functional leadership

Risk Management

Agile methodologies

GMP compliance

Education

Degree in a science or engineering discipline

Tools

Microsoft Project

Job description

AMS is a world-leading independent developer and manufacturer of innovative tissue‑healing technology, focused on quality outcomes for patients and value for payers. AMS has a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices and internal sealants, which it markets under its brands LiquiBand®, RESORBA®, LiquiBandFix8®, LIQUIFIX™, Peters Surgical, Ifabond, Vitalitec and Seal‑G®. AMS also supplies wound care dressings such as silver alginates, alginates, and foams through its ActivHeal® brand as well as under white label. Since 2019, the Group has made seven acquisitions: Sealantis, an Israeli developer of innovative internal sealants, Biomatlante, a Frenchικαν developer and manufacturer of surgical biomaterials, Raleigh, a leading UK coater and converter of woundcare and bio‑diagnostics materials, AFS Medical, an Austrian specialist surgical business, Connexicon, an Irish tissue adhesives specialist, Syntacoll a German specialist in collagen‑based absorbable surgical implants and Peters Surgical a global provider of specialty surgical sutures, mechanical haemostasis and internal cyanoacrylate devices. AMS's products, manufactured in the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic and Israel, are sold globally via a network of multinational or regional partners and distributors, as well as via AMS's own direct sales forces in the UK, Germany, Austria, France, Poland, Benelux, India, the Czech Republic and Russia. The Group has R&D innovation hubs LSUedin the UK, Ireland, Germany, France and Israel. Established in 1991, the Group has more than 1,500 employees. For more information, teha webbsite see www.admedsol.com

AMS provides equal employment opportunities for all applicants. We highly value and encourage diversity across our workforce meaning that no one will be discriminated against because of their gender, race, age, nationality, disability, or any other protected characteristic as prohibited by law.

What will this role involve?

• Planning, controlling and monitoring technically complex R&D product development projects.
• Project‑related leadership of multifunctional cross‑location teams to achieve the project goals.
• Participation in the evaluation of the project proposal, the development of the project mandate and the identification of stakeholders including the co‑ordination of resource allocation with line managers and clients and be responsible for communication management.
• To follow the company’s Product Development Process and present at key decision points to business unit management team and Project Review Board.
• To oversee Design Control activities, including ensuring appropriate document approval.
• To oversee the Risk Management process for new product development and life‑cycle management projects, ensuring compliance to ISO 14971.
• Keep all stakeholders informed of progress and issues. Reporting project status via the New Product Development Process (NPD process).
• Active management of project risks, issues and conflicts.
• To form strong relationships and coordinate activities with internal and external customers, including external business partners, vendors, contractors and test houses.
• To apply comprehensive and skilled knowledge of engineering/ scientific principles to the design, development and manufacture of medical devices.
• The jobholder is responsible to follow company and quality损 procedures and maintain training records, including ensuring compliance with relevant GMP, GLP, Fach & Safety standards.
• To perform all reasonable tasks requested of them by their manager

What we’re looking for?

• In-depth knowledge and understanding of projects work and adherence to deadlines, with proficiency in both waterfall and Agile methodologies.
• Proficient knowledge and understanding of Medical Device product development procedures and processes.
• Proficient knowledge of GMP/ISO13485/European MDR (EU 2017/745)/EN4600/FDA Quality System Regulation.
• Proficient knowledge of Risk Management - ISO 14971.
• An understanding of submission types: CE‑marking pathways, FDA 510(k)/PMA, pre‑sub/pre‑IDE meetings, labelling, and regulatory timelines.
• Cross‑functional leadership: Skill in coordinating across R&D, regulatory, quality, clinical, supply chain, manufacturing, marketing, and legal teams.
• Empathy, adaptability, active listening, and anticipation of user needs are indispensable.
< screenshots>Organization, Reporting & Communication: Using rigorous planning, risk logs, stakeholder alignment, precise status updates, and escalation strategies. Clear communication with technical and non‑technical audiences alike.
• Thorough understanding of test procedures.
• Educated to degree level in a science of engineering discipline as a minimum.
• Attention to detail and analytically minded.
• Familiarity with PC Systems and appropriate software, including Microsoft Project.
• Ability to analyse test results, compare against acceptance criteria and present a report.