Senior Regulatory Affairs Specialist
Company: Baebies Inc.
Posted on: May 15, 2022
Description: Baebies is a medical device company that develops
and commercializes newborn screening and near-patient testing
products for children and adults to enable early disease detection
and comprehensive diagnosis. Guided by the vision that everyone
deserves a healthy start," their mission is to save lives and make
lives better for all by bringing new technologies, new tests, and
new hope to children, parents, adult patients, and healthcare
professionals worldwide. Job purpose As part of the Regulatory
Affairs team the Senior Regulatory Affairs Specialist will be
responsible for bringing new products to global markets. The Senior
Regulatory Affairs Specialist Activities include regulatory
submissions, registrations and listings, globally. The Senior RA
Specialist will assure compliance with applicable medical device
regulations, guidance and standards for jurisdictions where devices
are marketed. Assists in creation and maintenance of documents
required to demonstrate compliance to medical device
regulations.Duties and responsibilitiesSubmissions
- Write, analyze, and edit technical documents to support 510(k),
Qsub, IVDR and other global submissions.
- Work with other departments and communicate the submission
requirements when documents are needed for regulatory
- Maintain and update regulatory authorizations, such as 510(k)s,
Canadian medical device licenses, and CE dossiers for EU, etc.
- Assure that appropriate maintenance of registrations occurs
including renewals, device listings, site registrations,
supplements for changes and annual reports.
- Support approval in other regions as required.
- Prepare responses to regulatory authorities' questions within
assigned timelines.Regulatory Strategy
- Stay abreast of regulatory procedures, guidance documents,
standards, and changes in regulatory climate.
- Assist with determining regulatory strategies for new products
and new territoriesVigilance and Post Market Surveillance
- Assess device related complaints for medical device reporting
requirements. Compile and submit reportable events to relevant
regulatory authorities in a timely manner.
- Handle recalls and field actions, if required. Review and
approve complaint files.
- Review product labels and review promotional material for
compliance with applicable regulations and technical
- Participate in post-market surveillance activities and produce
summary reportsSite Support
- Support external regulatory agency audits, providing regulatory
input to minimize potential for findings of non-compliance.
- Assess and document regulatory impact of product design changes
in jurisdictions where product is licensed. Participate in design
projects as an independent reviewer.
- Review and approve product change orders and deviations,
considering regulatory impact of proposed changes.
- Maintain QMS procedures related to regulatory responsibilities,
product licensing, and regulatory reporting.
- Participate in internal audit program.
- Support other projects, as required.
- Train site on new regulationsManage
- Work assignment for the RA specialist(s) to ensue on time
delivery of team actions
- Staff Development . Requirements: QualificationsRequired -
Minimum of 3 years regulatory affairs experience within a medical
device organization and a degree or higher in a scientific
discipline. - Excellent written and verbal communication skills
with the ability to listen, articulate and advocate - Proactive,
high performance, result oriented - Technical system skills (e.g.
MS office applications, databases, efficient online research) -
Manage multiple projects and deadlines - Ability to identify
compliance risks and escalate when necessary - Demonstrate both
creative and critical thinking skill - Experience with 510(k)
and/or IVDR submissions an advantage - Experience with global
registrations - A qualified internal Auditor would be an advantage
- Regulatory Affairs Certificate in Medical Device Working
conditionsThe regulatory specialist will routinely work remotely.
As needed for team activities, submissions and audits they will be
required to be on site. There may be the occasional need to work
evening and/or weekends in response to feedback from regulatory
authorities. Physical requirementsThe job is desk based. There are
no specific physical requirements Compensation & BenefitsBaebies
offers a dynamic and welcoming work environment surrounded by
intelligent, driven, and creative people. Guided by the vision that
everyone deserves a healthy start, our team is devoted to our
customers and to advancing technology in early disease detection
and comprehensive diagnosis. At Baebies, we look for people who are
innovative, dedicated to our mission, and constantly striving to
improve the status quo. In addition to competitive, market-driven
compensation, Baebies provides a comprehensive employee benefits
package including: - 100% employee premiums for Medical & Vision
coverage - 100% employee and family premiums for Dental coverage -
401K Matching - Stock Options - 4 Weeks PTO - 14 Paid Holidays per
year - Paid Employee Life Insurance - Onsite free gym membership &
classes - . . . Much more! Baebies, Inc. is an equal opportunity
employer. NO RECRUITERS OR AGENCIES, PLEASE.
Keywords: Baebies Inc., Durham , Senior Regulatory Affairs Specialist, Other , Durham, North Carolina
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