Quality and Regulatory Director
Position: Quality and Regulatory Director
Posted: September 3, 2020
Etac is a world-leading developer of ergonomic mobility aids for people at all stages of life – from small children to the elderly. We offer high quality, state-of-the-art products for numerous care situations, that aim to enhance activity regardless of physical circumstances. Our heart lies in the solutions that optimize quality of life for the individual, their family and caregivers. Etac – Creating Possibilities.
For more than forty years, the Etac Group has developed products and services that creates possibilities for users and carers. Today we offer a wide range of solutions for mobility with; manual wheelchairs, innovative products for bathing and toileting and aids for daily living (under the Etac brand); solutions for patient transfer (Molift and Immedia); a world-leading range of solutions for pediatric use (R82 and Convaid); and advanced pressure care (Star).
The Director of Quality and Regulatory Affairs North America will be responsible for overseeing the Quality and Regulatory Affairs activities in Torrance (CA), Charlotte (NC) and Freeburg (IL). The Director of Quality and Regulatory Affairs North America will report to the President North America, will be part of the North America management team and a key member of the global QA/Reg team as well as supporting the global Operations team. The business includes the following product areas/brands:
- R82 is a globally leading pediatrics brand covering a broad range of products including seating, standing, and walking aids, hygiene products, car seats and buggies. R82 operations are based in Denmark, and North American sales and logistics are based in Charlotte, North Carolina.
- Convaid is a pediatrics brand with a strong market position in North America, focusing on wheelchairs and strollers. Convaid was acquired by Etac in December 2015, and covers a full business system including sales, marketing, manufacturing and logistics, all based out of Torrance, California.
- Molift and Immedia. In addition to pediatrics, Etac Group is building a strong global position within patient handling. Molift covers a range of patient lifters including both standing lifters and ceiling mounted lifters. Molift operations are based in Scandinavia, and North American sales and logistics are based out of Charlotte, North Carolina. Immedia covers a range of manual handling products such as special sheets and follows the same organizational set-up as Molift.
- Etac Group also has a range of manual wheelchairs and hygiene products such as commodes and shower chairs that are marketed under the Etac brands. These products also follow the similar organizational set-up as Molift.
Tasks and responsibilities
- Coordinate and oversee the global Regulatory & Quality requirements for 6 US products manufactured at Torrance location and consult for with Etac supply companies in Sweden, Denmark and Poland on FDA compliance of over 50 products sold in the US market.
- Ensure compliance with company global policies and initiatives
- Maintain and develop the quality processes in the US organization and in close cooperation with the Operations department track and present quality KPIs on a regular basis
- Manage the CAPA process including opening new CAPAs, ensure efficient management of ongoing CAPAs and closing of completed CAPAs together with a cross functional team
- Coordinate Complaint Management process
- Manage Medical Device Reporting (MDR)
- Manage Corrections and Removals process (recalls)
- Manage required regulatory submissions and registrations, primarily for US and Canada
- Support regulatory submissions for European countries in collaboration with the European team
- Prepare and manage audits from regulatory bodies
- Engage in Quality and Regulatory due diligence during potential acquisition processes
- Ensure regulatory compliance and stay updated on trends in the industry and evolving regulatory requirements
- Develop and maintain a network in the industry and in the regulatory field