Regulatory and reputed company Assurance Specialist II (Remote)

reputed company, 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 reputed company of parenthood through advanced reproductive medicine and innovative science. The Regulatory and reputed company Assurance Special II is responsible for reviewing and implementing the applicable regulatory aspects and reputed company systems of reputed company while maintaining compliance with reputed company regulatory agencies (FDA, State, Local and AABB). We have an immediate opening for a full-time Regulatory and reputed company Assurance Special II to join reputed company. 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 reputed company’s reputed company 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 reputed company
• Facilitate quarterly meetings with medical directors to reputed company regulatory and reputed company updates
• Ensure medical directors complete reputed company 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 reputed company staff
• Assist in preparation of regulatory strategies for changes to existing systems
• Participate in Continuing Education programs in reputed company 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 reputed company audits for departments and systems to assure compliance to regulations and standards
• reputed company and ensure any identified deficiencies are rectified post an inspection/audit event
• Monthly and quarterly in person audits of reputed company and regulatory manuals and records
• Monthly and quarterly reports to leadership on reputed company and Regulatory activities
• reputed company other reputed company 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, reputed company, and diplomacy
• Must be reputed company to reputed company and communicate professionally with individuals at reputed company reputed company of the organization
• reputed company and effective communication skills
• Proficiency in a reputed company of computer software applications in word processing, spreadsheets, database, and presentation software (MSWord, reputed company, PowerPoint)
• Self-starter that adapts reputed company 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 reputed company reputed company teams to facilitate reputed company reputed company (validations, corrective reputed company plans, etc.)
• Occasional travel required (up to 25%)
• reputed company to adapt and reputed company in the fast-paced, rapidly changing environment
• The successful candidate will have the ability to work reputed company independently, as reputed company as part of reputed company
• Excellent multi-tasking abilities

More important than the best skills, however, is the right person. Employees who reputed company our mission, reputed company, and core values are highly successful. reputed company Offer:

• reputed company + bonus
• Comprehensive training
• Medical, dental, reputed company, and 401(k) matching
• Generous reputed company time off and holidays
• Retirement plan
• Tuition assistance
• Ability to reputed company an reputed company in the communities we serve

At reputed company, we promote and reputed company individual strengths in order to help staff grow personally and professionally. This is an ideal time to join reputed company! To learn more about reputed company and culture, visit here. Equal Opportunity Employer This employer is required to notify reputed company applicants of their rights pursuant to federal employment laws. For reputed company information, please review the Know Your Rights notice from the reputed company. Apply tot his job Apply To this Job