WorcesterRecruiter Since 2001
the smart solution for Worcester jobs

Regulatory Affairs Advisor Medical Advice

Company: Robsco Search
Location: Worcester
Posted on: November 20, 2020

Job Description:

Prepare regulatory assessments and plans for new products and design changes. Prepare or direct the preparation of regulatory submissions for product approval/clearance, including 510(k) premarket notifications. Participate in interactions with regulatory agencies needed to obtain product approval/clearance. Support Investigational Device Exemption submissions. Participate on product development Core Teams assisting with regulatory assessments and planning; reviewing product development and clinical protocols and reports to ensure collection of appropriate data for regulatory submissions; and participating in risk assessments and design reviews. Review labeling, training, and promotional materials for compliance with claims and applicable regulations. Assess product and manufacturing changes to determine regulatory impact. Provide ongoing surveillance and analysis of FDA and international medical device regulations for impact on products and regulatory procedures. Communicate regulatory requirements to management, Core Teams and others; particularly new and revised regulatory requirements. Develop and maintain regulatory procedures and policies to ensure compliance to applicable regulations. Support US and international product registrations. Support post-market regulatory compliance activities for US and international products. Qualifications: Education: BS or higher degree in engineering, science, health care or similar required. Experience: 10+ years regulatory experience with at least 5 years regulatory experience in Medical Devices, including demonstrated experience in preparing successful FDA 510(k) submissions. Experience in preparing international submissions is a plus. Experience in acting as a liaison to and communicating with regulatory agencies. Akron, Ohio. Must possess strong oral and written communication skills.

Keywords: Robsco Search, Worcester , Regulatory Affairs Advisor Medical Advice, Healthcare , Worcester, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Healthcare Jobs


Registered Nurse (RN) - Cath Lab
Description: Cath Lab opening in Troy, New York. This and other rn jobs brought to you by NursingJobCafe.com Adventure Awaits Accountable is leading the way in Travel Nursing - Run by Nurses for Nurses, we Care for (more...)
Company: Accountable Healthcare Staffing
Location: Troy
Posted on: 12/4/2020

LPN / LVN Immediate Need - LTC & HH Travel Nurse
Description: Nationwide Travel Nurse Jobs - Medical Surgical Med Surg Licensed Practical NurseHCEN client agency who has put in a special request to fill numerous Nationwide LPN / LVN Nursing vacancies. br ul (more...)
Company: HealthCare Traveler Jobs
Location: Troy
Posted on: 12/4/2020

Registered Dental Assistant (Troy,NY)
Description: Are you ready to take your dental career further than you ever thought possible Do you get excited about working closely with dentists and dental staff to provide the best care
Company: Stynt
Location: Troy
Posted on: 12/4/2020


ICU Travel Registered Nurse opening in Taunton, Massachusetts
Description: Aya Healthcare has an immediate opening for the following position: ICU, Registered Nurse in Taunton, Massachusetts. This is a 8 week contract position that requires at least one year of experience.
Company: Aya Healthcare
Location: East Providence
Posted on: 12/4/2020

ICU, MICU - Medical Intensive Care Units - Travel RN
Description: Travel Nurses Needed - RN Intensive Care Units br Nationwide Registered Nurse Travel Jobs br The Travel Nurse Season is here and it showsFind great travel assignments with the best in compensation (more...)
Company: RN Travel HealthCare Jobs
Location: Troy
Posted on: 12/4/2020

Travel Long-Term Acute Care Registered Nurse (RN)
Description: MAS Medical Staffing is more than a staffing agency. We are facilitators of careers, support systems for families
Company: MAS Medical Staffing
Location: Concord
Posted on: 12/4/2020

Travel Long-Term Care Certified Nursing Assistant (CNA)
Description: MAS Medical Staffing is more than a staffing agency. We are facilitators of careers, support systems for families
Company: MAS Medical Staffing
Location: East Providence
Posted on: 12/4/2020

Pediatric's Travel Nurse (Peds RN)
Description: Travel Nurses Needed - Pediatric RN Specialties br Nationwide Pediatric Travel Nursing JobsPediatric Intensive Care Unit, Pediatrics, Pediatric OncologyHCEN has numerous request for RN Candidate Profiles (more...)
Company: RN Travel HealthCare Jobs
Location: East Providence
Posted on: 12/4/2020

Internal Medicine --- Outpatient
Description: OPPORTUNITY HIGHLIGHTS St. Peters Health Partners Medical Associates, P.C. SPHPMA has an excellent full time employment opportunity for an Internal Medicine physician to join an established practice (more...)
Company: Trinity Health
Location: Troy
Posted on: 12/4/2020

Travel Nurse Newborn Nursery RN
Description: Travel Nurse Newborn Nursery RN Registered NurseNursery Travel Nurse Jobs Assignments br Looking for a Newborn Nursery travel assignment You are in the right place, the HCEN Network of staffing agencies (more...)
Company: RN Travel HealthCare Jobs
Location: Troy
Posted on: 12/4/2020

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Worcester RSS job feeds