Local medical devices manufacturer Stentex is currently looking for a Senior Regulatory Affairs Manager.
MAIN PURPOSE OF JOB:
Lead RA team to ensure that all regulatory requirements, necessary to obtain timely regulatory approval to meet the business objectives for all Stentex products (e.g. commercial medical devices and devices for clinical investigational use) within the Russian Federation defined country are met. Ensure the Regulatory Compliance with registration certifications and Stentex Quality system are maintained in accordance with Stentex and country regulations.
MAIN JOB DUTIES/RESPONSIBILITIES:
- Works cross-functionally with other Stentex departments to develop aligned strategic plans to ensure the timely regulatory approvals in the most economical way. Responsible for coordination of regulatory projects and assigns them to direct reports and monitors and communicate progress.
- Ensure the organization develops and maintains communications with national regulatory authorities to assure effective working relationships by providing a framework for negotiations with Government officials on issues and taking advantage of opportunities to influence their regulations and requirements.
- Effectively address, implement and ensure compliance with current Russian Federation regulatory compliance requirements that apply to the business.
- Analyse regulatory guidance documents, emerging requirements and anticipate the impact of changing regulations on development plans and regulatory strategies.
- Handle complex regulatory compliance issues and ensure these are communicated to the appropriate levels of Stentex leadership.
- Interface and communicate effectively with our Medtronic contacts in international locations. (Strategic Business Unit) and in Moscow.
- Identify and establish best practices within the Regulatory Affairs department including continuous improvement initiatives.
- Manage the day-to-day technical issues and requests through effective interaction with R&D, Operations, Engineering and Marketing, etc.
- Issue and review with management an annual organizational development plan which focuses on risks and critical needs.
- Develops proficiency in any applicable regulatory requirement that applies to our products and ensures new or changed requirements are communicated within the organization.
- Issue and review with management an Annual Operating Plan (AOP) to address strategic investment needs and functional support needed for businesses to meet their objectives regarding regulatory submissions and maintenance of approvals. Ensure the alignment with business strategies.
JOB QUALIFICATION, KNOWLEDGE, EDUCATION:
- Master in medical/technical area
- Experience in regulatory affairs within medical devices company is obligatory
- Proven track record of relevant working experience as regulatory and quality expert in a highly regulated environment
- People management experience
- Proven track record of successful Change management experience
- Excellent English verbal and written skills
- Good communication/presentation skills
- Willingness for business trips
- Attractive compensation level
- Annual bonus
- Medical insurance
- Mobile compansation
- Opportinities for career development
- Location: Skolkovo innovation center