Regulatory Affairs Manager Latin America

Industry:

Company: GC America Inc

GC Group is a leading global family-owned research and development, manufacturing and commercial enterprise which develops innovative dental products and technologies based on evidence-based dentistry. GC Group has its global headquarters in Lucerne, Switzerland with its heritage and roots in Japan where it was founded in 1921. GC America is a subsidiary of the GC Group and is based out of the Chicago area. GC America manufactures and distributes dental materials, orthodontics, and biomaterials for dental professionals and patients throughout the world. GC America is also a recipient of the coveted Deming Prize for total quality management (TQM) making it the first U.S. dental company in the United States to earn the world’s oldest and most widely recognized total quality award. GC America has exciting growth plans and is seeking new associates who passionately care about working hard, constantly learning and being challenged, and most importantly helping others. We offer unique career opportunities both locally and globally for motivated and capable GC associates as our daily work serves a vital link to the health and wellbeing of patients and communities around the world.

The Regulatory Affairs Manager performs duties associated with the channel of information and creation/filing of regulatory documents required by GCA companies, divisions, departments (GCA, LATAM, GCOA, GCMA) to support company operations both domestic and globally to maximize revenue and profit.

Requirements

ESSENTIAL DUTIES and RESPONSIBILITIES:

• The position requires a basic understanding, a Bachelor of science degree in a science field plus a minimum of 3 to 5 years’ experience with Regulatory Submissions and in a regulatory function in the Pharma, Device or Healthcare Industry. Regulatory experience in a multinational corporation with operations in North and Latin America while not required will be an advantage.
• Managerial skills required. The ability to plan, coordinate, organize, work in teams, lead projects, and control costs are managerial skills the ideal candidate must possess.
• Document collection across functions and departments for the purpose of registering GC America Products in the Latin American Region and any other assigned region according to the format required by each country.
• Prepare Dossiers for Regulatory submission, coordinate documentation formatting and maintenance within the documentation management system, maintenance of relevant regulatory lists for LATAM. Tracking documents, provision of timely support to LATAM countries, evaluating regulatory compliance and working with the team to maintain good relationships with regulatory partners, scheduling and prioritizing activities related to regulatory submissions.
• Proficiency in Microsoft office (Excel, Word, PowerPoint) is required and the ability to use Chemgees or similar database software to create SDSs will be an advantage.
• Evaluate available technical and scientific information for compliance with regulatory requirements and communicating per departmental processes and workflow. Experience with regulatory submissions to FDA, Anvisa, COFEPRIS or any other Latin American authority desired.
• Responsible for operational Regulatory affairs activities, including coordination, preparation, and review of dossiers and documents. Previous experience submitting 510ks, preparing LTFs, SOPs and updating central database, cGMP required in the medical device industry required.
• Knowledge of regulatory environment in any Latin American country or any assigned markets and communicate with the Team.
• Prepare, compile, format and maintain pre-market documentation required by assigned territories including product registrations, technical files, Safety Data Sheets Preparation, Complaints, etc.
• Working with relevant technical expert departments in cross functional teams requires interpersonal and communication skills. The ideal candidate should have excellent communication and interpersonal skills and be a good team player. The position requires the ideal candidate to work across functions with Product Engineering, Quality Assurance, Marketing, Product Management and LATAM commercial section on regulatory documentation, formatting, compliance, and activities in assigned markets under the leadership of the Senior manager and the Director of Regulatory Affairs.
• Work with product management, customer service, and other departments to prepare, compile and maintain post market documentation and resolve customer issues.
• Prepare adequate responses to regulatory authority requests in different Latin American countries to different regulatory authorities in collaboration with the LATAM and Regulatory Affairs Team.
• Work across functions with Product Engineering, Quality Assurance, Marketing, Product Management and LATAM commercial section on regulatory requirements in assigned markets under the leadership of the Senior manager and the director.
• Work with other GC Companies Regulatory Teams to support requests from global GC entities providing documentation such as BER, SER and other tests when required.
• Support communication, tracking and reporting of critical quality incidents as required.

MINIMUM QUALIFICATIONS:

• Bachelor’s Degree in a science field
• 3 to 5 years Regulatory Experience in a Regulatory Function in Pharma, Device or Healthcare
• 3 to 5 years of experience in Regulatory Affairs or Quality Assurance.
• Multinational regulatory experience including North and Latin America, while not required, will be an advantage.
• Managerial skills required. The ability to plan, coordinate, organize, work in teams, lead projects, and control costs are managerial skills the ideal candidate must possess.
• Experience working across teams and functions in a multinational organization will be an advantage.
• Experience with FDA and Other Regulatory Authorities Required.
• Ability to work across functions with Product Engineering, Quality Assurance, Marketing, Product Management and LATAM commercial section on regulatory requirements in assigned markets under the leadership of the Senior manager and the director.
• In addition to experience with FDA, prior experience working with COFEPRIS, ENVISION, and any other regulatory authority in Latin America, while NOT a requirement, will be an advantage for the ideal candidate. Bilingual skills in one of these languages; Spanish, Portuguese, Japanese in addition to English while not REQUIRED will be an advantage for the ideal candidate.
• Excellent communication and interpersonal skills. The successful candidate must have the ability to relate with and communicate with others respectfully in a team. Excellent interpersonal and communication skills are required for this position.
• Microsoft Office Suite, Chemgees, Salesforce, SAP

Additional information:

• This position is located in Chicago, and a minimum of three days of in-office presence is required.

BENEFITS:

• Hybrid work schedule
• 401(k) through Fidelity and company matching 10%
• Dental insurance with Delta Dental PPO
• Health insurance BCBS Illinois PPO
• Health Savings Account
• Vision Insurance EyeMed
• 401k Retirement Plan 10% Match
• Short-Term & Long-Term Disability
• Company Paid Life Insurance
• Accident Insurance
• Paid Vacation & Sick Days
• Holiday Pay (including an extra paid week off between Christmas & New Years)
• Annual Associate Holiday Party
• Annual Associate Golf Outing
• Holiday Bonus
• Profit Sharing Bonus
• Education Reimbursement Program
• Free lunch