Our client is currently seeking a driven and ambitious Manager, Regulatory and Quality to join their team. This is a unique opportunity for a highly motivated professional who has a go-getter attitude.
1) Manage regulatory affairs and quality assurance
2) Maintain the company's regulatory and quality management system
3) Prepare regulatory submission documents and technical documents necessary for product approval, marketing authorizations and etc.
4) Ensure company's products and processes are compliant with applicable mandatory standards
5) Monitor and manage activities pertaining to the regulatory and quality departments
6) Prepare operational and capital budget plans, as directed to ensure provision of regulatory and quality services to the company
7) Act as liaison with external regulatory and quality authorities to ensure compliance
8) Monitor international regulatory changes and coordinate pertinent information to company
9) Provide reliable input and perform tasks related to regulatory and quality affairs in the design, development and manufacturing verification and validation and servicing of the company's produce and service offering
10) Coordinate the compiling and submission of product approval and/or marketing authorization submissions on a worldwide basis, as directed, work with representatives from other internal departments
11) Investigate maintain and report adverse events and product problems to national and international regulatory authorities
12) Develop and maintain a working relationship and serve as primary contact with external auditing services
13) Oversee audit program
14) Develop and maintain working relationship with quality representatives of the company's critical suppliers, conduct supplier assessment visits on concert with operation management
15) Collect organize and present regulatory and quality data for the quality and senior management meetings in support of CTO
16) Act as coordinator to the quality assurance committee and quality management review meetings
17) Participate and provide quality and regulatory support to the product development, special QAC, product launch and other team efforts
More questions? Want to know the Salary range? Keep reading.
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1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the medical device industry is strongly preferred
4) Preference will be given to people who have recent experience in regulatory and quality management
If you imagine yourself working for an excellent company whose employees believe in team work and making great contributions to the industry, this could be a golden opportunity for you.
Sterling-Hoffman Life Sciences is the premier recruitment firm in North America for companies involved in the research, clinical development, manufacturing and distribution of drugs and devices that allow patients to live healthier and more fulfilling lives. Leveraging a network of relationships in every major city – including New York, San Francisco, Raleigh-Durham, Chicago, Dallas, Denver and Los Angeles – Sterling-Hoffman Life Sciences is ideally positioned to assist fast growing CROs, pharmaceutical companies, biotech firms and medical device players in their quest to recruit the best people.