Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Carlsbad, California
Position Summary Ensures regulatory compliance of GenMark in vitro diagnostic products, which include existing commercial product offerings as well as new diagnostic products in the development pipeline.
Essential Duties and Responsibilities
* Represents Regulatory Affairs (RA) and interacts with cross-functional departments to provide RA guidance.
* Ensures compliance with all relevant ISO and FDA GMP regulatory requirements (e.g., ISO 13485, 21 CFR 820).
* Prepare hardcopy and electronic information packages for submission to regulatory agencies in the US and International Markets.
* Write and/or edit submission documents using regulatory templates.
* Participates on new product development core teams as the regulatory lead to provide guidance on strategies to comply with the appropriate regulatory requirements.
* Ensures regulatory milestones and timelines for assigned projects are met.
* Develops regulatory commercial strategies for GenMark s IVD products.
* Reviews product labeling to assure compliance with regulatory requirements.
* Reviews promotional material to assure claims and indications are compliant with GenMark policies and applicable regulatory requirements.
* Monitors, tracks, and actively assesses evolving FDA regulations, guidance, points-to-consider, warning letters and policies to ensure continued compliance.
* Participates in Material Review Board (MRB) and Product Quality Committee (PQC) meetings to provide guidance on potential regulatory reporting requirements.
* Reviews and assesses proposed change orders for regulatory reporting.
Education and Experience:
* BS in life sciences, engineering, or equivalent required
* Advanced degree (e.g., MS or Ph.D.) in scientific or regulatory discipline preferred
* Regulatory Affairs Certification (RAC) preferred
* Minimum of five (5) years of experience in Regulatory Affairs - preferably in medical device, in vitro diagnostic or medical device industries
* Track record of FDA interactions
* Extensive Knowledge of US medical device regulations and regulatory processes.
* Must be a hands-on, self-directed, detail oriented and conscientious individual
* Complete work in a timely, accurate and thorough manner
* Must be able to think and work both tactically and strategically to provide financial and operational needs to GenMark s business
* Effective analytical problem solving, judgment and decision making skills are required
* Strong time management and organizational skills in a dynamic, constantly changing environment
* Ability to read, write and analyze complex documents
* Demonstrate superior technical writing skills.
* Ability to respond effectively to sensitive inquiries, customer inquiries or complaints as well as communicate effectively both orally and in writing with management, peers and individuals
* Ability to work effectively, exhibit a professional manner and establish constructive working relationships
Work Environment The essential functions of the job are performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and biotechnology laboratory environments. The employee may be exposed to hazardous chemicals, blood borne pathogens and automated equipment.
GenMark Dx does not accept agency submittals. Please do not forward resumes to our Executive team, Management team, or any current GenMark employee for review. GenMark Dx is not responsible for any fees related to unsolicited resumes.
GenMark is an Equal Opportunity Employer and Prohibits Discrimination and Harassment of any kind: GenMark is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at GenMark are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. GenMark will not tolerate discrimination or harassment based on any of these characteristics. GenMark encourages applicants of all ages. GenMark participates in E-Verify. GenMark is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.