Regulatory Affairs Saudi Arabia Manager

**Job Function**:
Regulatory Affairs Group
**Job Sub Function**:
Regulatory Affairs
**Job Category**:
People Leader
**All Job Posting Locations**:
Riyadh, Saudi Arabia

The role of Regulatory Affairs KSA & DPS MEA Lead is to drive and lead commercial strategies for Ortho portfolio in MEA region in partnership with EMEAC Franchise Liaison & MEA commercial BU representatives.

In addition, the role of Regulatory Affairs Lead of Saudi Arabia is to ensure timely registration of medical devices in accordance with European and National Legislation in Saudi Arabia compliant placing on market MDs relevant to business strategy. The Regulatory Affairs Lead will ensure regulatory compliance with applicable law, internal regulatory processes and procedures.

The RA Lead supports regulatory matters and projects. Is involved in RA policy shaping - outreach and Regional RA strategy alignment.

**Key responsibilities**:
**Regulatory Affairs Saudi Arabia & DPS Lead**:

- Leads & drives portfolio planning for MEA Surgery per alignment with Ortho representatives - MEA commercial and franchise Liaison.
- Accelerates strategic products registration to meet launch readiness - Top NPDs and NPIs.
- Ensures proactive approach in problem solving, key stakeholders’ engagement.
- Leads and drives DPS strategies and projects.
- Identify opportunities for cost saving and involve financial value

**Regulatory Affairs KSA RA** Lead**:

- In charge of regulatory shaping and outreach coordination in respective region, closely interacting with local Regulatory authorities and Trade Associations
- Assess impact of regulatory changes on products, business/licenses and patients
- Interfaces with RA team members (Franchise and Regions), commercial partners to oversee the regulatory aspects for proactive involvement
- Project Lead / Representative for RA Outreach Group on RA Projects
- Ensures regulatory compliance of medical devices and medicinal in product portfolio of JnJ MedTech, within timelines
- Provides RA support to Tender management, and Reimbursement, Business, Distributors, and Franchises
- Leads ongoing efforts to improve RA processes
- Ensures audit readiness in RA area and represents RA during the audits and HA inspections
- Provides routine communication and updates to management on regulatory compliance
- supervise Copy Review process
- Provides feedback to operations on problems related to regulatory compliance and ensures timely and consistent escalation of events
- Provides leadership, guidelines and development to direct reports
- Manages work and performance of direct reports
- Identifies opportunities for cost saving and involves financial value
- Meets all applicable quality, legal and HCC compliance requirements
- Performs other work-related duties as assigned by manager.

**Required Qualification and Core Competencies for the role**:

- Minimum 8 years of experience in Regulatory affairs in health care industry Medical Devices sector
- At least 4 - 6 years period of people management experience.
- Makes decisions based on local requirements - to execute effectively.
- Demonstrates RA requirements and communicates regulatory and compliance needs to Business
- Displays expertise in local and EU Medical Devices regulations
- Relationship and network of contacts in the Competent Authorities and Trade Associations
- Excellent interpersonal skills - building and maintaining relationships with internal and external partners
- Excellent organizational skills and attention to details.
- Excellent English skills.
- Results & Performance Driven
- Sense of Urgency
- Strategic Thinking
- Accurate and intuitive problem solving, critical thinking, conflict management

**Leadership Behaviors Require**
- **LIVE OUR CREDO**: Puts the needs of Our Credo stakeholders first, pursues the highest standards of quality, safety, compliance & ethics and Ensures everyday actions contribute to Our Purpose
- ** CONNECT**: Builds internal and external relationships based on respect, Collaborates openly across boundaries and acts as a team player.
- ** SHAPE**:Inspires and contributes ideas that challenge thinking, demonstrates resilience and agility to drive and adapt to change.
- ** Grow**: Develops self and others to reach their goals, engages in open & honest conversations and Drives performance by managing energy and taking ownership for outcomes.