Job Position : Quality Regulatory Manager

Job Description :

Key Responsibilities
Develops, implements, maintains and coordinates Companies’ Quality and Regulatory Program and Compliance Plan, ensuring all necessary elements are addressed.
• Provides necessary quality and regulatory reports to the senior leadership team
• Ensures the maintenance of necessary compliance reporting mechanisms and documentation to meet contractual and regulatory requirements including:
o Oversight of regulatory affairs & reporting ensuring timelines and review of trends.
o Vendor/Supplier audit and compliance/reporting including pre-delegation reviews.
o Non-compliance with specific elements of Companies’quality Plan and Code of Conduct from any source.
o Any identified instances of conflicts of interest for all Companies’ employees
o On-going and/or completed compliance related investigations.
• In coordination with appropriate department managers, oversee and assist managers in the creation of corrective action plans for identified compliance issues and concerns as required as well as monitors and ensures corrective action plans are implemented.
• Maintain oversight of and compliance with all healthcare regulations including, but not limited to, FDA, CE Mark, HIPAA Regulations, PDMA Regulations, PhRMA Code Guidelines for Interactions with Healthcare Professionals, Anti-Kickback Statutes, Federal False Claims Act, Physician Payments Sunshine Act, various central government and state regulations.
• Understand and explain regulatory compliance programs or issues and comply with constantly changing regulatory requirements.
• Provide training in person and/or via Webex/ Lync to field team members on regulatory requirements.
• Create/update and review quality and regulatory related SOPs and training materials as required.
• Monitor training documentation for completion by staff members
• Advise staff members on regulatory issues/questions that may arise.
• Monitor Deviations by staff members and assist in implementation of corrective and preventive actions.
• Participate in external and internal audits, including occasional “ride-alongs\" with field personnel to audit for compliance.
• Maintain working relationships with external vendor partners
• Oversee risk assessment activities as well as testing efforts to deliver quality products in healthcare domain
• Study and keep abreast on Indian regulations and laws related to healthcare/medical devices and services (including data retentation and residency laws)

Educational Qualifications
Please mention minimum grade/percentage, if over and above organizational guidelines, as well as names of institutes, if applicable)

Desired Role
General knowledge of FDA regulations, CE Mark, HIPPA,HL7, 21 CFR Part 11(electronic record-keeping), good documentation skills
Preferably 3+ years experience in healthcare/medical device/pharmaceutical industry
Commonsense approach to quality and regulatory systems while designing plans and overseeing compliance
Exceptional oral and written communication skills
Process/procedure oriented individual with ability to multi-task; strong organizational skills a
Proven capability to set up management processes and review and assure delivery methodology must

Knowledge & Skills (Indicate which criteria are mandatory)
Knowledge of healthcare related regulatory and compliances in India as well as globally.
Knowledge of medical device quality system regulations(21 CFR 820, ISO 9001/13485)
Strong stakeholder management skills
Strong written and verbal communication skills, including presentation skills

Company Name : Client of Symmetrical

Location : Navi Mumbai

Job Code : HR/SGS/089

Experience : 5

Job Salary

Last Date To Apply : 30-04-2014

Posted on : 07-03-2014