Sr. Regulatory Affairs Specialist
8415 154th Ave NE Redmond, Washington 98052 | Contract
Position Title: Sr. Regulatory Affairs Specialist
Position Description: Our Eastside client is looking to add a Sr. Regulatory Affairs Specialist to their team.
- Minimum 5 years of experience working for a medical device company in regulatory affairs
- Creating and maintaining technical files compliant to MDD 93/42/EEC (for Class I and Class IIa devices)
- Generating risk management annual reports compliant to ISO 14971
- Familiarity with MEDDEV 2.7/1 revision 4
- Ability to work independently and amongst a team with minimal supervision.
- Effective problem solving with a high attention to detail.
- Excellent computer and presentation skills including Microsoft Word, Excel, and PowerPoint.
- Generating clinical evaluations compliant to MEDDEV 2.7/1 revision 4
- Reviewing protocols & reports for cleaning and sterilization validations
- Research methodology
- OBL certification processes related to technical files
- Strong organizational and time management skills.
- Work effectively on cross functional teams.
- Ability to lead investigations to resolve quality issues.
- Excellent written and oral communication skills.
- Ability to review, analyzes, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions.
Primary Duties & Responsibilities:
- Update technical files for compliance
- Generate risk management annual report
- Other duties as required
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding and exciting work opportunities for our candidates.
Benefits Package: Protingent offers competitive salary, 100% paid health insurance, education/certification reimbursement, pre-tax commuter benefits, Paid Time Off (PTO) and an administered 401k plan.