Regulatory Affairs Manager Medical Device Sustaining Projects
Posted on: December 8, 2018
Job Description Summary
We are currently recruiting for a Regulatory Affairs Manager Medical Device Sustaining Projects) in our corporate office in Alpharetta, GA.
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 requirementsPosition 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 Requirements:
- Bachelors 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 industryAvanos 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 .
Associated topics: bilingual, care, care physician, family practice, nocturnist, physician md, practice physician, practitioner, primary care, urgent
Keywords: Avanos, Alpharetta , Regulatory Affairs Manager Medical Device Sustaining Projects, Executive , Alpharetta, Georgia
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