Regulatory Compliance Specialist

The Quality and Regulatory Specialist is responsible for maintaining and managing the daily operations of the Patterson Quality Management System. Manages compliance activities with responsibility for results in terms of ongoing effectiveness of the QMS and of conformance to applicable regulation, standard and company policies. Supports activities related to design history, risk management, supplier controls and regulatory registrations and submissions.

**Major Duties**:

- Oversees daily operations of the QMS for compliance to requirements of applicable regulations and standards, including 21 CFR Part 820, ISO 13485, CMDR, GMPs and others as applicable.
- Proposes and implements improvements to the QMS and its procedures and processes to maintain ongoing effectiveness.
- Manages Corrective and Preventive Action (CAPA) and Supplier CAPA records from initial investigation and root cause analysis, into action planning and effectiveness in a timely and compliant manner.
- Manages complaint review, investigation and reporting in a timely and effective manner.
- Manages field action risk assessment, bounding, inventory control, communications, effectiveness checks and reporting/closure.
- Supports documents and records control process.
- Participates in management reviews and generates quality system metrics in support of management review.
- Coordinates audit schedule and participates in internal/external audits and may lead supplier audits.
- Stays current on industry trends in relation to compliance.
- Provides support and contributes to other compliance activities and areas as necessary.
- Other duties as assigned.
- Occasional travel required.

**Critical Competencies**

Analysis: Able to visualize, articulate, and solve complex problems and concepts and to make decisions that make sense based on available information.

Collaboration: Understands the importance of relationships to ensure success; open to other viewpoints in the interest of achieving best possible outcomes. Builds positive relationships, uses tact in sensitive situations; listens well to various points of view; relates well to others at all levels.

Flexibility: Easily adapts to new methods and procedures; helps others embrace disruptions as opportunities for improvement; responds to change initiatives with positive outlook and energy.

Action Orientation: Takes initiative and action with a drive to achieve and be successful; seeks out challenging situations; encourages others with positive and energetic support. Able to prioritize time and tasks with little direction in order to complete work on schedule; organized and efficient; able to bring order to complex and competing demands.

Results Focused: Able to define and create visibility around success metrics and how they will be measured; proactively seeks out progress updates from team members to ensure risk mitigation to defined success criteria; willingness to put forth the necessary effort to ensure challenges and obstacles are overcome and keep projects on track.

Interpersonal Effectiveness: Maintains credibility by following through with commitments; takes responsibility for mistakes; exhibits professional and appropriate emotional response to situations.

**Job qualifications**:

- Bachelor’s Degree in engineering, Science or related field or equivalent work experience.
- 2-4 years' experience with quality management systems and regulatory compliance in the medical device or related regulated field.
- Excellent oral and written communication skills, in French and English.
- Developing working knowledge of quality management systems and regulatory submission requirements, preferably in an FDA-regulated environment (FDA 21 CFR Part 820 and ISO 13485 requirements).
- Demonstrated ability to review and quickly assimilate complex regulatory compliance information and standards.
- Ability to work effectively within a team and as an individual contributor in a fast-paced changing environment - multi-tasks, prioritizes and meets deadlines in timely manner.
- Strong verbal and written communications with ability to effectively communicate at specialist and line management levels in the organization.
- Strong organizational, analytical, and creative problem-solving skills and track record contributing to teamwork practices with a moderate impact on functional objectives.
- Highly self-motivated and directed and able to carry out responsibilities with latitude and limited supervision.
- Ability to prioritize and execute tasks in a high-pressure environment.
- Strong customer service orientation.
- Experience working in a team-oriented, collaborative environment.
- **Patterson n’est pas juste un simple lieu de travail, c’est un partenaire qui se soucie de votre succès.**

L’une des marques distinctives de Patterson, ce sont les personnes de talent qui incarnent notre culture ̶ être axés sur les gens, en constante évolution et centrés sur les résultats. La croissance professionn