Risk Manager & Design Control Engineer - Bonesupport AB at Haeger & Carlsson | Executive Search & Interim AB

, , Sweden -

Full Time

Start Date

Immediate

Expiry Date

14 Jan, 26

Salary

0.0

Posted On

16 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Risk Management, Design Control, ISO 14971, Medical Device Regulations, FDA Quality System Regulation, ISO 13485, Technical Writing, Documentation Skills, Regulatory Changes, Collaboration, Communication Skills, Project Management, Class III Implants, Combination Products

Industry

Staffing and Recruiting

Description

Come and join BONESUPPORT as Risk Manager & Design Control Engineer. This is an opportunity to apply your expertise in risk management and design control to ensure patient safety and high-quality products. About BONESUPPORT AB BONESUPPORT™ AB is a leading Scandinavian biotechnology company based in Lund, Sweden. BONESUPPORT™ AB aims to become a global leader in Ortho biologics by optimizing bone biology to treat bone disorders. BONESUPPORT ™ AB develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs. BONESUPPORT’s bone graft substitutes are based on the patented technology platform CERAMENT. About the role As Risk Manager & Design Control Engineer you will plan, lead and implement Risk Management activities according to ISO 14971 across Product Lifecycle Management (PLM) and New Product Development (NPD). You will also support Design Controls activities, including labelling, and ensure that products remain in compliance with applicable regulatory requirements and updated standards, guidelines and regulations throughout the lifecycle by updating, reviewing and establishing engineering documents and Standard Operating Procedures (SOPs). You will hold main responsibility for the risk management process in accordance with ISO 14971 and collaborate closely with Quality, Regulatory, Research, Clinical and Operations, as well as external partners. Qualification Requirements Technical academic background at Bachelor level or higher At least four years’ relevant experience from the medical device industry In‑depth knowledge of ISO 14971 and medical device regulations (e.g., EU MDR, FDA Quality System Regulation and ISO 13485) Hands‑on experience with Design Controls as per FDA and ISO 13485 Strong technical writing and documentation skills Ability to interpret and implement regulatory changes into existing systems Collaborative mindset with excellent communication and project management skills Fluency in English Preferred Qualifications Knowledge and experience with Class III implants and combination products Swedish/Scandinavian language skills We believe you are driven and collaborative. You combine a sharp eye for detail with a passion for quality. You communicate clearly, influence across teams, and thrive both strategically and hands-on in fast-paced environments—always with a genuine interest in medical devices and product lifecycle management. Why BONESUPPORT At BONESUPPORT you will be working together with skilled, dedicated people who enjoy working in a fast growing and innovative organization. They offer a dynamic and stimulating workplace and strive for generating great teamwork, innovation, passion, and performance – which is reflected in impressive employee engagement figures. BONESUPPORT believe in their journey and take pride in what they do. Location: Lund, Sweden Please apply through haegercarlsson.com Questions are answered by: Alexander Johansson, +46 (0)73 – 77 77 233, alexander@haegercarlsson.com Rolf Carlsson, +46 (0)70-316 12 68, rolf@haegercarlsson.com

Responsibilities

You will plan, lead and implement Risk Management activities according to ISO 14971 across Product Lifecycle Management and New Product Development. You will also support Design Controls activities and ensure compliance with regulatory requirements throughout the product lifecycle.