Sunstar Americas, Inc. is a global leader in the oral care industry and the manufacturer and distributor of GUM oral care products and solutions. We serve dental professionals and consumers in 80 countries worldwide and are driven by a mission: to enhance the health and well-being of people everywhere through high-quality, innovative oral care products and solutions.
The Director Regulatory Affairs will develop, lead and execute the corporation’s regulatory compliance strategy including Drugs and Medical devices. To ensure complete compliance with all FDA, QSR, cGMP, and other federal and state regulations, and with corresponding international regulations in all markets served. The scope of this position impacts all products (device, drug, food, supplement) in all life-cycle phases (design planning, manufacturing or subcontracting, post-market surveillance), and services (marketing communications, order acceptance and fulfillment) that affect customer satisfaction in all channels of trade.
- Must have Pharma and Medical Device experience
- To provide leadership for the Regulatory Affairs function at all SAI facilities.
- To ensure compliance with international GMPs, US FDA regulations, etc. in all countries of manufacture and exportation.
- To serve as the Official Contact with FDA and related regulatory authorities at the federal, state local and international level.
- To work with executive management and aid in determination of extraordinary matters (recalls, market withdrawals, regulatory matters, compliance issues, etc.).
- To ensure timely regulatory filings for the company (device listings, establishment registrations, MedWatch filings, adverse event reporting, etc.). Responsible for establishment and maintenance of filing procedures, tracking, re-certification, etc.
- To serve as consultant and advisor for new products, facilitating the timely introduction of safe and effective new products while ensuring that all customer and regulatory requirements are researched and communicated to the design team, are subsequently met prior to launch, and are monitored for compliance in the production and post-market phases,
- To ensure international market growth by providing the technical, quality and regulatory documents that are required to register products in each country.
- To continually monitor the effectiveness of the production and business processes that impact customer satisfaction (innovation, marketing communication, order fulfillment, purchasing and manufacturing), to develop, lead and execute corporate strategy aimed at maximizing the results of those processes, and to report progress to the corporate Officers globally.
- To thoroughly research all guidance (ICH, FDA, QSR, etc.) related to regulatory matters, and report on same to the appropriate personnel.
- To educate corporately on areas of responsibility as appropriate. Provide training (or training direction) necessary and increase knowledge corporation-wide of RA guidelines
- To hire, train, motivate, evaluate and develop direct and indirect reports for optimum performance and compliance. Evaluate department structure for maximum efficiency.
- To provide as-needed, guidance to parent company subsidiaries (i.e., Canada, Latin America, and EMEA) regarding regulatory issues.
- Bachelor’s degree in sciences or Engineering is required.
- Advanced degree in science or business management is preferred.
- At least 10 years in a significant corporate regulatory within an FDA-regulated drugs and devices industry with 8 years demonstrated leadership
- Comprehensive knowledge of FDA, cGMP (mandatory).
- Well versed with 21 CFR 803 (Medical Device Regulations)
- Experience with international GMP/RA compliance requirements, especially EMEA, Latin America and Canada.
- Proven record for exceeding quality and business goals
- Thorough understanding and working knowledge of 510(k) & PMA submissions, and ANDAs
- Outstanding leadership skills
- Expertise to command regulatory compliance activity in alignment with corporate policies and industry regulations
- Computer proficiency: Microsoft Office
- Strong organizational and time management skills – high attention to detail
- Self-starter with strong interpersonal skills
- Communication skills: Written, Oral and Presentation
- Ability to direct cross functional resources in a fast-paced work environment
- Ability to interpret and accommodate legislation
- Comprehensive insurance coverage that includes Medical, Vision, Life and disability insurance plans along with enhanced Dental benefits.
- Company Paid Life & AD&D and Optional Life Insurance
- Flexible Spending and Health Savings Accounts
- Pet, Legal and Identity Theft Insurance Plans
- Employee Assistance Program
- Wellness program including an onsite fitness center.
- 401K retirement plan with 5% employer match (Pretax and Roth options)
- 401k profit sharing contribution based on company performance
- Paid holidays and generous paid time off.
- Competitive annual bonus and sales incentive programs
- On-site café featuring daily specials with dinner-to-go options.
- Miles of beautifully maintained walking trails.
- Numerous employee appreciation events throughout the year.
- Professional development and training classes
- Employee discounts on oral care products