Regulatory Affairs Specialist
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.
The Regulatory Affairs Specialist will be part of the team bringing new products to global markets. Activities of the Regulatory Affairs Specialist include regulatory submissions, registrations and listings, globally. Assure compliance with applicable medical device regulations, guidance and standards for jurisdictions where devices are marketed. Assist in creation and maintenance of documents required to demonstrate compliance to medical device regulations.
Duties and responsibilities
- Write, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents.
- Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.
- Maintain regulatory files e.g. Standard Technical Files
- Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports.
- Assist in preparing responses to regulatory authorities’ questions within assigned timelines.
- Produce product labels for investigational use products and for submissions
- Maintain product UDI listings in country-specific databases.
- Manage document translations
- Ensure the website document portal is current
- Support external regulatory agency and 3rd party audits
- Perform internal audits of the quality management
Author and Update Procedures
- Stay abreast of regulatory procedures, guidance documents, standards, and changes in regulatory climate
- Update procedures when required to meet changes in regulation.
· Minimum of 1-2 years regulatory affairs experience within a medical device organization and a degree 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)
· Good Time Management Skills
· Ability to identify compliance risks and escalate when necessary
· Demonstrate both creative and critical thinking skill an advantage
· A qualified internal Auditor
· Regulatory Affairs Certificate in Medical Device
· Documented training on current medical device standards and regulations is an asset (e.g. MDSAP, EU MDR, ISO 13485, etc.)
The 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.
Sitting or standing for long periods of time. Viewing a screen for long periods of time.
Compensation & Benefits
Baebies 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.