the smart solution for Alpharetta jobs

Regulatory Affairs Manager - Medical Device Sustaining Projects

Company: Avanos
Location: Alpharetta
Posted on: December 7, 2018

Job Description:

Job Description Summary

We are currently recruiting for a Regulatory Affairs Manager - Medical Device Sustaining Projects) in our corporate office in Alpharetta, GA.Job Description


As an individual contributor, the function of the Interventional Pain Management Regulatory Affairs Manager is to support the Regulatory Affairs Department in Region and Domestically by ensuring compliance with company standards and the applicable US and International medical device/drug regulations for electromechanical and software based devices. The experienced individual will prepare product submission documentation, evaluate design/manufacturing changes for effects on regulatory filings, and provide guidance to project teams as it relates to application of regulatory requirements to support the development and growth of innovative electromechanical and software based serialized devices. They will actively participate with developing strategies with project teams, and work with in Region RA counterparts/and or Distributors while aligning with company priorities/initiatives. The individual will execute tasks and play a consultative role by partnering across internal business functions. The individual may also have/lead discussions with Regulatory Bodies. The individual will manage interactions with the in-country distributors and affiliates regarding product registrations, Regulatory Compliance, Quality Compliance, and Post Market Reporting. The individual will also support product import/export into the Region.


Provide Regulatory Affairs leadership to project teams developing electromechanical devices for pain management (e.g., develop regulatory requirements matrices, creative and compliant regulatory strategies, timelines, and prepare domestic and international submissions)
Effectively communicate, prepare, and manage regulatory submissions, and must assure that deadlines are met
Advise cross-functional teams on upcoming compliance dates internationally regarding electrical safety standards, and evolving software standards (i.e. cybersecurity, HIPAA, etc.)
Create and execute Regulatory and Quality procedures to support the development of innovative medical devices in compliance with domestic and international regulations
Provide the regulatory support for product maintenance activities that include CAPAs, document change control, and business support
Monitor the development of regulatory initiatives that may impact the Pain Management device portfolio and communicate potential business impact to senior management
Provide interpretation and training of regulatory requirements to cross-functional team members
Effectively communicate with representatives from regulatory agencies to ensure product and facility compliance to regulations
Anticipate and assist in the resolution of regulatory challenges and recommend corrective action
Core job responsibilities for this function may include: Strategic Planning, SOP development, Lead development of regional regulatory strategy and update strategy based upon regulatory changes without supervision
Determine and communicate submission and approval requirements
May participate in risk-benefit analysis for regulatory compliance
Self-motivated and willingness to learn and proactively problem solve
Understanding compliance to Corporate and Regulatory procedures/ requirements and goals, and Regional Regulatory Requirements and communicating with stake holders to find a solution that meets the respective regulatory and compliance and customer requirements

Position Specific Accountabilities:

New product registrations, assessing changes to existing registrations, and maintaining registrations current for assigned products/geographies
Provide regulatory support for the Needles, Kits, and trays business through close collaboration with sustaining engineering and technical quality, along with business support to the kitting facilities in Nogales, Mexico, and Tucson, Arizona
Provide analytical, interpretive and evaluative solutions to complex problems through specialized Regulatory Affairs expertise based on an in-depth knowledge of technical (i.e. electronics and software) and business practices
Support Regional Import/Export Support
Support Regional Quality Matters
Demonstrate a strong degree of knowledge in excel spreadsheet maintenance, use of outlook tools, SharePoint, SAP based systems, and other computer programs used for tracking and reference
Maintain records and documents for established systems that support regulatory activities and requirements
Strong attention to detail, highly organized, and able to manage multiple projects simultaneously
Lead projects/initiatives
Develop and remain current on applicable internal procedures/process(s) and applicable regulations


Bachelor--s degree in a relevant discipline
5-8 years of experience in the medical device industry and/or Regulatory Affairs for medical devices
Relevant experience in electromechanical and software based devices, and/or anesthesia needles and convenience kits
Demonstrated computer skills and strong written and verbal communications, and International submission experience preferred/primary author (Canada, Latin America, EMEA, APAC)
Strong understanding and experience with process, manufacturing, product development, engineer, market research, marketing and legal matters involving medical device industry

Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law.

If you are a current employee of Avanos or Halyard Health, please apply here.

Keywords: Avanos, Alpharetta , Regulatory Affairs Manager - Medical Device Sustaining Projects, Healthcare , Alpharetta, Georgia

Click here to apply!

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

I'm looking for
in category

Other Healthcare Jobs

RN Inpatient Rehab Facility Services - nights
Description: Standard br br Qualifications: br br br Provides general nursing care to patients in hospital. Administers prescribed medications and
Company: HCA.
Location: Macon
Posted on: 12/15/2018

Occupational Medicine Physician - Physicians Only Apply - Perm
Description: Medical Doctors Only Apply. A Occupational Medicine Physician practice is
Location: Cleveland
Posted on: 12/15/2018

Psychiatry Physician Job in Macon, GA
Description: Psychiatric-Mental Health opening in Macon, Georgia. This and other physician jobs brought to you by
Company: Hayman Daugherty Associates, Inc
Location: Macon
Posted on: 12/15/2018

PT Physical Therapist Travel High Pay Rate in Macon, GA
Description: Advanced is now searching for the perfect candidate to fill a thirteen week assignment as a physical therapist in the Macon, GA area.
Company: Advanced Travel Therapy
Location: Macon
Posted on: 12/15/2018

Psychiatry Hospitalist Job in Macon, GA
Description: Psychiatric-Mental Health opening in Macon, Georgia. This and other physician jobs
Company: Hayman Daugherty Associates, Inc
Location: Macon
Posted on: 12/15/2018

Inpatient Medical Coder - Urgent Notice!
Description: PT FT to work at home. Pay DOE. You must be certified through AAPC or AHIMA - CCS, CPC, RHIT, RHIA with
Company: Mommy Jobs Online
Location: Cleveland
Posted on: 12/15/2018

RN, Charge/Preceptor, GI/Endoscopy Lab
Description: Northside Hospital is award-winning, state-of-the-art and continually growing. Constantly expanding the quality and reach of our care to our patients and communities creates even more opportunity for (more...)
Company: Northside Hospital
Location: Alpharetta
Posted on: 12/15/2018

Registered Nurse (PD)
Description: Registered Nurse - Peritoneal As a Peritoneal Dialysis Registered Nurse PD RN , you educate your patients on how to do their own dialysis from their homes, and you take responsibility for the complete (more...)
Company: DaVita
Location: Alpharetta
Posted on: 12/15/2018

Physical Therapist / Therapy (PT) - Outpatient 13 Week Contract
Description: A great Outpatient Clinic is looking for an experienced or newly graduated, hard-working Physical Therapist / PT to join their growing team for a 13 week assignment The Physical Therapist / PT is responsible (more...)
Company: Centra Healthcare
Location: Alpharetta
Posted on: 12/15/2018

Healthcare - internet/phone req.
Description: Our company is seeking outgoing, energetic people who have a passion for helping others work
Company: Myownhomecareer
Location: Alpharetta
Posted on: 12/15/2018

Log In or Create An Account

Get the latest Georgia jobs by following @recnetGA on Twitter!

Alpharetta RSS job feeds