Beschreibung
Overall responsibilities- Ensure appropriate medical surveillance and post-market review for different medical device products
- You as a Team leader will assess and resolve product issues that have potential clinical implications for patient population including MDR event reporting decisions.
- The Post Market Risk Manager is the medical professional for the Companies USA's Medical Device/Vigilance Reporting system.
- Responsible for coordination of Health Hazard Analysis, consultation with medical consultants as necessary, as well as involvement in post market actions such as product recall.
Responsibilities
- Provide guidance and direction in the determination and assessment of clinically significant post market issues
- Provide direction/ medical opinion on all MDR decisions
- Work cooperatively with Product Development groups to foster understanding of regulatory requirements regarding post market issues
- Review clinical and trade publications for relevant news
- Provide general medical knowledge for regulatory submissions group as deemed necessary to ensure adequacy of support for all claims, pertaining to safety, efficacy and performance.
- Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
Ideal Background
- Fluent English (oral and written)
- Knowledge of internal and external bone fixation devices and implants
- Experience or general medical knowledge of Orthopedic, Spine, and Craniofacial/ Maxillofacial implants and instruments.
- General knowledge of the FDA requirements for medical devices and MDR reporting.
- 10 years medical experience in nursing.
EDUCATIONAL REQUIREMENTS:
- Registered Nurse or Nurse Practitioner.
Place of work:
- Switzerland¨
- Office-based, 5-day/week
More Details:
- 6 Months fulltime
- Location: Switzerland
- 100% onsite
- Start date: a.s.a.p
Please notice: European citizens are preferred
For a confidential discussion about regulatory affairs projects in Switzerland, or to apply, then send your CV to or call me.
I am a specialist recruitment consultant in regulatory affairs for the Pharmaceutical & Biotechnology industry. I offer a number of search options within the industry with a special focus on Switzerland.
If you are a Pharmaceutical professional looking for your next opportunity, then please don't hesitate to get in contact with me. Alternatively if you are currently looking for skilled individuals for the development of your organisation, then I can certainly help.
Your personal contact:
Kristina Bröckel
Regulatory Affairs Consultant
Tel:
mailto:
To find out more about Real please visit www.realstaffing.com