Regulatory and Quality Assurance Specialist II (Remote)

Shady Grove Fertility • Full-time • Rockville, Maryland, United States • 1w ago

US Fertility, the nation’s largest partnership of physician-owned and physician-led top-tier fertility practices, a national network of premier IVF laboratories, are united under a shared mission to deliver the joy of parenthood through advanced reproductive medicine and innovative science.

The Regulatory and Quality Assurance Special II is responsible for reviewing and implementing the applicable regulatory aspects and quality systems of the company while maintaining compliance with all regulatory agencies (FDA, State, Local and AABB).

We have an immediate opening for a full-time Regulatory and Quality Assurance Special II to join our team. The schedule for this position is Monday-Friday 9am-5pm, and requires travel to Marlborough, MA once per month or as needed.

How You'll Contribute:

Implement, monitor, maintain, and improve the company’s Quality System
Implement, monitor, and maintain a document control system
Interpret and assure conformance to federal and state regulations that are applicable to the products produced/processed
Assure appropriate licensure is held and maintained by the company

Facilitate quarterly meetings with medical directors to provide regulatory and quality updates
Ensure medical directors complete all signoffs as required
Assure compliance to international regulatory agencies
Tracking and trending of laboratory, cryogenic, andrology, and deviation systems
Maintain and improve deviation/non-conformance system
Report events to regulatory bodies as applicable
Assure training and competency of all staff
Assist in preparation of regulatory strategies for changes to existing systems
Participate in Continuing Education programs in related field
Participate in planning and implementation of regulatory systems, document/change control and validation activities
Establish and maintain good working relationships with department heads, regulatory authorities, and government agencies
Implement and oversee audits for departments and systems to assure compliance to regulations and standards
Track and ensure any identified deficiencies are rectified post an inspection/audit event
Monthly and quarterly in person audits of quality and regulatory manuals and records
Monthly and quarterly reports to leadership on Quality and Regulatory activities
Perform other related duties as assigned by management

What You'll Bring:

Bachelor’s degree or equivalent combination of training and experience
Must have a high level of interpersonal skills to handle sensitive and confidential situations. Position continually requires demonstrated poise, tact, and diplomacy
Must be able to interact and communicate professionally with individuals at all levels of the organization
Clear and effective communication skills
Proficiency in a variety of computer software applications in word processing, spreadsheets, database, and presentation software (MSWord, Excel, PowerPoint)
Self-starter that adapts well to change in a fast-paced, dynamic environment
Prior laboratory experience preferred
Knowledge of industry, Federal and State regulations, licensing processes
Strong aptitude for analyzing data, audit processes and reconciling records
Demonstrated organizational skills and the ability to prioritize and coordinate multiple processes
Excellent interpersonal skills and ability to work as part of a multi-disciplinary team and build and maintain effective working relationships.
Excellent verbal & written communication skills
Ability to work as part of a multi-disciplinary team
Ability to organize and lead collaborative teams to facilitate quality projects (validations, corrective action plans, etc.)
Occasional travel required (up to 25%)
Able to adapt and thrive in the fast-paced, rapidly changing environment
The successful candidate will have the ability to work well independently, as well as part of a team
Excellent multi-tasking abilities

More important than the best skills, however, is the right person. Employees who embrace our mission, vision, and core values are highly successful.

What We Offer:

Competitive pay + bonus
Comprehensive training
Medical, dental, vision, and 401(k) matching
Generous paid time off and holidays
Retirement plan
Tuition assistance
Ability to make an impact in the communities we serve

At US Fertility, we promote and develop individual strengths in order to help staff grow personally and professionally. This is an ideal time to join our team!

To learn more about our company and culture, visit here.