Regulatory Affairs Manager - Medical Devices
Karo Healthcare, Sweden
Job Description
Karo is at an exciting stage in its journey to become a 1 billion European leader in consumer healthcare.
Our purpose is to deliver better everyday health through smart choices and after a series of exciting acquisitions, we now own a strong portfolio of consumer healthcare brands, including E45, Decubal, Nailner, CCS, Multi-Gyn, Flux, Paracet, Alpha Foods, Remescar and Nutravita across Global markets.
Alongside a continued active Mamp;A agenda, our target is to accelerate the growth of our current brand portfolio, growing 7-10% CAGR over the next 3 years. For our priority brands, this means double-digit growth, equating to growth well ahead of the category. To achieve this, we must serve consumers better than the competition and for Karo, this requires a transformation in how we build our brands, innovate and go to market.
Responsibilities
- Set the regulatory strategy for compliance of the medical device portfolios
- Emphasis of this role will lie on the clinical evaluation compliance (medical device) with related standards and regulations and will require close collaboration with the Medical Affairs team to set the pre-clinical, clinical and post marketing follow-up strategies to plan the work
- Act as sparring partner to the brand manager and support in setting the brand plans from a regulatory perspective.
- Support product claim/indication substantiation
- Assure life cycle management of the technical dossier of medical devices according to ISO 13485 and related regulations and communicate with regulatory bodies
- Assure impact assessment of changes as applicable and compliance upon product development and/or design changes.
- Act as the regulatory business contact with partners distributing Karo products and ensure regulatory compliance in those markets through labelling review, document submission etc.
- Support international registrations as part of the business development of Karo and assure continuous growth and expanded business of Karo
- Establish the regulatory strategy in different projects such as NPD (new product development, all product categories) and be the RA representative in the project group
- Presentation of regulatory related material in meetings and to company management
- Act as Person Responsible for Regulatory Compliance (PRRC), in accordance to Article 15 of the MDR
- Liaise with relevant departments for maintenance of above compliance (e.g. QA and PMS)
Requirements
Expertise
- University degree or equivalent in Engineering/Natural Science or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices. Or higher education in Engineering/Natural Science or another relevant scientific discipline and at least four years of experience in regulatory affairs or in quality management systems relating to medical devices
- Excellent computer skills including experience with systems and databases
- Fluent verbal and written English, other languages are plus
- Worked in cross-functional projects concerning both commercial and technical aspects of business, in the Life Science industry
Skills and competencies
- Excellent communicator; able to handle many and various types of contacts
- Organized way of working, attention to detail as well as seeing the full picture
- 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 and collaborative
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 amp; Inclusive environment. We are looking for qualified candidates irrespective of gender, gender identity, sexual orientation, ethnicity, race, religion, national origin, disability or age.