Senior 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.
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 responsibilities
- 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 submission.
- 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.
- Stay abreast of regulatory procedures, guidance documents, standards, and changes in regulatory climate.
- Assist with determining regulatory strategies for new products and new territories
Vigilance 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 standards.
- Participate in post-market surveillance activities and produce summary reports
- 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 regulations
- Work assignment for the RA specialist(s) to ensue on time delivery of team actions
- Staff Development
· 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
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.
The job is desk based. There are no specific physical requirements
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.