Manager, Post-Market RA and Compliance

Full job description
#ChangeMakers



Ready to make an impact?

We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss.

We empower our employees to perform and make an impact, to question the status quo, to drive change, to stay ahead of the competition. From the first Dental Implant in 1+74 to the latest Digital Solution – we do things differently than others

We deliver innovation based on evidence. This is part of our employer culture as well as an exceptional team spirit that truly encourages diversity and a powerful “can-do” attitude.


#WeChangeDentistry every day. Be part of it.


Position Summary:

This position is responsible for performing, coordinating, and leading tasks that ensure Straumann complies with United States and Canadian regulations for the handling and management of complaints and adverse event reporting. Responsibilities include documenting, processing, and closing of customer complaints in addition to maintaining positive customer relationships while maintaining compliance with company policies. This position is responsible for supporting the quality system (CAPA program, NCMRs, etc.) and acts as the representative for Straumann Canada with respect to the Quality System and Regulatory Affairs functions as the liaison to Health Canada. This position may involve handling of human tissue products. This position is also responsible for evaluating team performance using performance and quality metrics, supporting continuous improvement projects, and providing feedback to the complaint team.

Job Responsibilities:

This position is responsible for, but not limited to, the following:

Overall administration of Straumann Canada's complaint activities:
Development of schedules, assigning and monitoring work, gathering resources, implementing productivity standards, and resolving operational problems
Monitor quality of work and procedures for direct reports
Coach, develop, and monitor the Complaint team performance through quality reviews and feedback of complaints and customer communications
Handle challenging and escalated customer issues to resolution o Coordinate training and on-boarding of new hires
Development and continuous improvement of department processes and procedures o Document complaints in the complaint management system
Communicate with clinicians, office staff, and device manufacturers as needed to obtain additional information to process complaints o Process incoming complaint product shipments (i.e., open and process mail) with possible exposure to bloodborne pathogens
Review complaints to determine whether regulatory authority reporting and/or assessment by the Product Safety Officer is warranted
Perform complaint shipment to the Designated Complaint Handling Unit (DCHU) o Review complaint analysis reports and close out customer complaints according to applicable regulatory requirements and company policies and procedures
Maintain excellent working knowledge of company’s products
Communicate with external and internal customers via the regulatory telephone queue and department email inbox
Act as the Complaint Management SME during audits/inspections
Overall administration of Straumann Canada's quality activities:
Acts as a liaison between Straumann Canada and Health Canada
Coordinates the filing of required documentation to Health Canada
Coordinates recall activity affecting the Canadian market
Assists with product quarantine and incoming inspections
Conducts regulatory review of new 3rd party products in Canada
Maintains local regulatory files (Mandatory Problem Reports, Recalls, and Product Licenses)
Maintains local Quality System documentation (procedures, complaints, CAPA's, audit reports, NCMR's, product quarantine, and release records)
Supports the review and approval of Straumann Canada's procedures
Assist in training personnel where applicable
Participates in Health Canada inspections and other third-party audits
The responsibilities listed herein are not intended to be a comprehensive list of the duties and responsibilities of the position. The duties and responsibilities may change without notice.

Management Responsibilities:

Direct: 1 -2 Complaint Specialists
Physical Attributes:

May sit or stand for extended periods of time.
Utilize dexterity abilities to perform typing, operate a computer and other office equipment, to perform filing, and related job responsibilities and attention to detail competence.
Spend significant time reading both on paper and on a computer.
Travel less than 5% both domestically and internationally.

Work Environment:

General office environment.
Noise level in the work environment is usually quiet to moderate.
Minimum Qualifications:

Bachelor’s Degree or High School Diploma/GED OR 10+ years customer service experience
Fluent in French
Minimum of three (3) years prior dental, customer service, and/or complaint handling experience
Preferred Qualifications:

Basic computer skills (Microsoft Office)
Experience working in a regulated industry
Basic knowledge of SAP
Excellent organizational skills with strong attention to detail and the ability to multi-task effectively
Strong record of reliability with demonstrated follow through
Excellent written and oral communication skills
Optimistic in high-stress environments
Leadership aptitude and potential
Strong decision-making and problem-solving skills with sound judgement

Additional Information:

Whether you’re looking to build your career, improve your health, or brighten your SMILE, we offer generous benefits to help you achieve your goals.

Very Competitive total compensation plans (some positions include discretionary bonus, or Performance Share Units).
A 401(K) plan to help you plan for your future with an employer match
Great health, dental and vision insurance packages to fit your needs to ensure you’re happy and healthy. Straumann contributes a healthy portion towards employees’ premium.
Generous PTO allowance - plenty of time to recharge those batteries!

Please understand that we do not need external support by recruiting agencies and consultants to fill this vacancy. Thank you for respecting this.


Videos To Watch:

https://youtu.be/3lq5BLAvIdQ


All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, ****** orientation, gender identity, national origin, or disability.

Employment Type: Full Time

Alternative Locations: Canada : Burlington

Travel Percentage: 0 - 10%

Requisition ID: 185+6