Global Regulatory Affairs Manager - Medical Device

Karo Healthcare

Stockholm
Permanent
Heltid

26 dagar sedan
Snabb ansökan

Karo Healthcare, a dynamic and growing company, is all about making smart choices for everyday healthcare. With a wide-ranging portfolio across seven categories including medical products, we own and sell over 100 brands in about 90 countries. Our portfolio includes such brands as E45, Pevaryl, Lamisil, Nutravita, Decubal and many others. Our core belief in empowering people to make intelligent health decisions drives our growth strategy, blending organic expansion and M&A. Since 2019, under EQT ownership, we're rapidly heading towards a €1 billion European leadership position in consumer health.Join us at Karo Healthcare on our exciting journey. We're currently looking for a Global Regulatory Affairs Manager - Medical Device for our office in Stockholm.As Global Regulatory Affairs Manager for Medical Devices you will be part of a global team with headquarter in Stockholm office and with following focus:Key responsibilities

Product Portfolio management and strategies
To assure life cycle management of the technical dossier of medical devices according to ISO 13485 and related regulations and communicate with regulatory bodies. This work will include work on areas such as risk management, biocompatibility, shelf life and post market surveillance.
To set the regulatory strategy for compliance of the medical device portfolios.
To collaborate with the Medical Affairs team on clinical evaluation compliance (medical device), with related standards and regulations, to set the pre-clinical, clinical and post marketing follow-up strategies to plan the work.
To act as sparring partner to the brand manager and support in setting the brand plans from a regulatory perspective.
Support product claim/indication substantiation.
To assure impact assessment of changes as applicable and assure compliance upon product development and/or design changes. Assuring ISO and EC compliance upon development and change.
To establish the regulatory strategy in different projects such as NPD (new product development) and be the RA representative in the project group.
To act as the regulatory business contact with partners distributing Karo products and ensure regulatory compliance in those markets through labelling review, country registrations etc.
To support international registrations as part of the business development of Karo and assure continuous growth and expanded business of Karo.
Project management & ownership: project participation and milestone delivery.
Design change to DHF for new product development as well as in change controls and update technical files.
Assure RA communication for product development/design change and RA evaluation/submission of change to notified bodies.
Ensuring appropriate production from lab scale to commercial scale including validation and qualification in close collaboration with QA team.
Assuring technical documentation for stability protocol and report.
Management of internal & external partners: effectively manage internal & external partners to ensure best-in-class communication and support.
A possibility to take on the role as Person Responsible for Regulatory Compliance (PRRC) and co-operate with Karo´s other PRRCs in this role.
Communication: proactively communicates project status, help needed, possible delays etc. to all relevant parties and proposes solutions for any issues.
Research: effectively conducts scientific research in order to address the needs of internal & external partners for commercial and technical issues.
Process improvements: proposes ways to improve the existing processes.

RequirementsCompetencies

Higher education in Engineering/Natural Science
Excellent computer skills including experience with systems and databases
Fluent verbal and written English
Knowledge in MDD/MDR and ISO13485. FDA regulation knowledge is a plus
Working experience in cross-functional projects concerning both commercial and technical aspects of business, in the Life Science industry
Working experience in an international environment within regulated industry for medical devices, 5-10 years’ experience

Skills and knowledge

Excellent communicator; able to handle many and various types of contacts
Good understanding and management of business relations
Good understanding of scientific and technical documentation
Able to prioritize and handle a varied and sometimes heavy workload
Work well under pressure and strict deadlines
Project planning skills and delivery of tasks within set timelines
Initiate necessary communication with colleagues, suppliers, customers when needed and follow up
Team oriented
Positive mindset and “can do” attitude

Benefits

Opportunity to create, grow, and encourage
Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
Flexible schedule and life work balance
Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
Very positive work environment in a young, international, and motivated team
Start-up spirit while being a part of the large international organization with strong values

Karo Healthcare has a Diverse & Inclusive environment. We are looking for qualified candidates irrespective of gender, gender identity, sexual orientation, ethnicity, race, religion, national origin, disability or age.

Karo Healthcare