Regulatory and Quality Assurance Specialist II (Remote)

Shady Grove Fertility; Rockville (MD); Remote; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a dedicated Regulatory and Quality Assurance Specialist II to join their mission of delivering joy through advanced reproductive medicine. This full-time position involves maintaining compliance with regulatory agencies, implementing quality systems, and ensuring the highest standards in a dynamic environment. The ideal candidate will possess a strong educational background, exceptional interpersonal skills, and the ability to thrive in a fast-paced setting. Join a team that values personal and professional growth while making a meaningful impact in the communities served.

Benefits

Competitive pay + bonus

Comprehensive training

Medical, dental, vision insurance

401(k) matching

Generous paid time off

Holidays

Retirement plan

Tuition assistance

Impact in communities served

Qualifications

• Bachelor’s degree or equivalent experience required.
• High level of interpersonal skills for sensitive situations.

Responsibilities

• Implement and maintain the company's Quality System.
• Ensure compliance with federal and state regulations.
• Facilitate audits and maintain good relationships with authorities.

Skills

Interpersonal Skills

Communication Skills

Analytical Skills

Organizational Skills

Multi-tasking Abilities

Self-starter

Education

Bachelor's Degree

Equivalent Combination of Training and Experience

Tools

MS Word

Excel

PowerPoint

Job description

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:

1. Implement, monitor, maintain, and improve the company’s Quality System
2. Implement, monitor, and maintain a document control system
3. Interpret and assure conformance to federal and state regulations that are applicable to the products produced/processed
4. Assure appropriate licensure is held and maintained by the company
5. Facilitate quarterly meetings with medical directors to provide regulatory and quality updates
6. Ensure medical directors complete all signoffs as required
7. Assure compliance to international regulatory agencies
8. Tracking and trending of laboratory, cryogenic, andrology, and deviation systems
9. Maintain and improve deviation/non-conformance system
10. Report events to regulatory bodies as applicable
11. Assure training and competency of all staff
12. Assist in preparation of regulatory strategies for changes to existing systems
13. Participate in Continuing Education programs in related field
14. Participate in planning and implementation of regulatory systems, document/change control and validation activities
15. Establish and maintain good working relationships with department heads, regulatory authorities, and government agencies
16. Implement and oversee audits for departments and systems to assure compliance to regulations and standards
17. Track and ensure any identified deficiencies are rectified post an inspection/audit event
18. Monthly and quarterly in person audits of quality and regulatory manuals and records
19. Monthly and quarterly reports to leadership on Quality and Regulatory activities
20. Perform other related duties as assigned by management

What You'll Bring:

1. Bachelor’s degree or equivalent combination of training and experience
2. Must have a high level of interpersonal skills to handle sensitive and confidential situations. Position continually requires demonstrated poise, tact, and diplomacy
3. Must be able to interact and communicate professionally with individuals at all levels of the organization
4. Clear and effective communication skills
5. Proficiency in a variety of computer software applications in word processing, spreadsheets, database, and presentation software (MSWord, Excel, PowerPoint)
6. Self-starter that adapts well to change in a fast-paced, dynamic environment
7. Prior laboratory experience preferred
8. Knowledge of industry, Federal and State regulations, licensing processes
9. Strong aptitude for analyzing data, audit processes and reconciling records
10. Demonstrated organizational skills and the ability to prioritize and coordinate multiple processes
11. Excellent interpersonal skills and ability to work as part of a multi-disciplinary team and build and maintain effective working relationships.
12. Excellent verbal & written communication skills
13. Ability to work as part of a multi-disciplinary team
14. Ability to organize and lead collaborative teams to facilitate quality projects (validations, corrective action plans, etc.)
15. Occasional travel required (up to 25%)
16. Able to adapt and thrive in the fast-paced, rapidly changing environment
17. The successful candidate will have the ability to work well independently, as well as part of a team
18. 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:

1. Competitive pay + bonus
2. Comprehensive training
3. Medical, dental, vision, and 401(k) matching
4. Generous paid time off and holidays
5. Retirement plan
6. Tuition assistance
7. 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.