Position leads the preparation of regulatory submissions based on specific project timelines and requests to the support the business with minimal supervision. Position provides global regulatory inputs to new product development projects and ensuring that the design outputs meet product registration needs leading to successful commercialization opportunities.
Essential Duties and Responsibilities:
Prepare and submit 510k premarket notification applications for submission to FDA
Prepare and submit reports and documents to support international regulatory submissions
Develop and submit IDE requests, develop and submit IDE reports as required
Work with clinical affairs to prepare clinical study reports
Sustaining RA Support:
Maintenance of establishment registrations and listings
Provide RA input to Operations functions for sustaining project activity
Provide RA input to change control and develop change impact assessment documents to gather information and document the required RA maintenance needed based on the proposed product change
Responsible for maintenance of product technical files and maintaining CE Marking
New Product Development:
Provide RA input to R&D functions for new product development project activity
Responsible for RA design inputs that lead to compliance with European directives and other country requirements (CMDCAS, etc.) and regulations
Promotional Material Review:
Provide support to currently marketed products, e.g., review labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval
Assist in review of labeling changes, advertising and promotional activities
BS / BA in degree in life sciences or physical sciences - required
3 years of experience in US and international regulatory approval process in medical devices or equivalent level of regulatory experience - required
Previous experience with regulatory submissions including IDE and 510(k) submissions for Class II medical devices - required
Experience with international regulatory and notified body submissions - required
Previous experience working with aesthetic medical devices - preferred
Knowledge, Skills and Abilities:
Good working knowledge of FDA labeling regulations, Quality System Regulations, Medical Device Directive and Canadian medical device regulations - required
Good communication skills - preferred
Merz North America is a specialty healthcare company headquartered in Raleigh, North Carolina and dedicated to the development and marketing of innovative quality products for physicians and patients across the United States and Canada. Merz products are distributed through two divisions, Aesthetics and Neurosciences, and are developed with the goal of improving patients' health and quality of life by delivering therapies that bring about real progress. Our future is promising, and we are committed to advancing new therapeutic options and improving patients' lives.
Why choose Merz?
Private company with a proud history.
Entrepreneurial spirit and culture.
Ability to be creative and innovative.
We foster a collaborative work environment.
Flexibility to design your experience.
Work in a fast paced industry.
Merz Vision and Values
Our vision is to become the most admired, trusted and innovative company in Aesthetics and Neurotoxins.
Our core values are the principles that unite and define the Merz way of working in every part of the world.
PERSIST IN INNOVATION
COMMIT TO CUSTOMERS AND COLLEAGUES
DELIVER TRUSTED RESULTS
Merz Operating Norms
ASSUME POSITIVE INTENT
OBLIGATION TO ENGAGE
COLLABORATE CROSS FUNCTIONALLY
MERZ IS ON THE MOVE!
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the companies legal duty to furnish information.
Merz Pharmaceuticals USA