Regulatory Affairs Director with strong leadership skills
Regulatory Affairs Director, Operations
Mölnlycke Health Care is a world leading manufacturer of single-use surgical and wound care solutions for the professional health care sector. The company is a global corporation with headquarters in Gothenburg, Sweden and 6,100 employees working in twentyfour offices and six plants across the globe.
On behalf of Mölnlycke Health Care we are now looking for a
Regulatory Affairs Director, Operations
The position will be based at the HQ in Gothenburg. You will be reporting to Senior Director, Global Regulatory Affairs. The Regulatory Affairs Director will be Regulatory Affairs representative in various internal management boards and external industry committees.
Position description
You will be leading and manage the regulatory staff in your team.
This includes the following key responsibilities:
- Work with strategic planning in developing procedures and policies for regulatory affairs.
- Anticipate regulatory obstacles throughout the product lifecycle and develop solutions.
- Strategic planning Premarket: provide strategic input to development teams, approve regulatory filing strategies. Postmarket: maintain annual licenses, registrations, approvals
- Be responsible for managing certain regulatory projects in the wound care division.
Qualifications and experience
· University degree, preferably in life science or material science
· At least ten years of management experience in a medical device and/or pharmaceutical industry, with a miminum of 5 years experience in regulatory affairs.
· Proven ability to apply the know-how and experience in a creative way.
· Experience from work in an international environment as department manager for at least five years.
· Excellent project management skills
· Knowledge of Medical device regulation, EMEA and Americas
· Quality Management systems; ISO 9000, 13485, MDD and FDA 21 CFR part 820 (quality system regulations) is preferred.
· We also think you have experience in Complaint handling, Product mangement and Risk management
- Fluent in English and preferably Swedish
Application
In this recruitment Mölnlycke Health Care is working with Hudson Global Resources. Please send your application (CV and personal letter in same document) to sofia.gedenryd@jobs.hudson.com, mark with SE_589533 in subject. If you have any questions please call Hudson Senior Consultant Lena Bello +46 708 50 49 96.
Please note: When you send your application, in regards to the above advertisement, your information will be registered in Hudson’s database. To be registered in Hudson’s database means that we might contact you in the future, regarding an assignment that might be of interest for you. All information concerning you will, of course, be handled confidentially and in accordance with PuL (The Personal Data Act). If you have any questions regarding this procedure you are welcome to contact us by e-mail, Sweden.info@hudson.com
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