Director / Senior Manager of Regulatory Affairs
Purpose of the Position:
The Director / Senior Manager of Regulatory Affairs will provide regulatory support for DxTerity’s key business functions across both domestic and international markets, including, but not limited to in-vitro diagnostic product development, clinical study support, laboratory developed tests, CLIA/CAP laboratory functions, commercialization, distribution (import/export), as well as ensuring the sustained success of marketed products. This role will lead the strategy and the preparation, review and submission of documents to FDA and other national authorities including post-market surveillance. This position will develop a variety of solutions to regulatory challenges and will exercise independent judgment in determining and communicating appropriate regulatory actions and requirements. This role will involve assessment of regulatory impact for new and modified Class I, II and III products, including identification of assumptions/risks/mitigations to develop and execute clear regulatory plans.
This role must be able to combine knowledge of scientific, regulatory and business issues to assure that products are developed, manufactured, and distributed according to all national, regional, and local laws and regulation pertinent to the manufacture and distribution of medical devices and/or IVDs. This position will collaborate with cross-functional teams, make presentations to executive management, and provide guidance to share regulatory affairs knowledge at all levels within the company.
This position acts as the regulatory affairs subject matter expert and is also responsible for continuous improvement of the DxTerity Diagnostics Quality System in compliance with the requirements of the FDA Quality System Regulations (21 CFR 820), ISO 13485, and DxTerity’s Quality Manual.
Supervises the Regulatory Affairs staff. May engage and supervise external consultants when needed to supplement DxTerity staff.
- Provides current regulatory intelligence and formulates regulatory strategies.
- Develop, coordinate and implement strategies to gain regulatory clearance for DxTerity Diagnostics’ products.
- Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle.
- Oversees coordination, preparation and timely submission of regulatory documents to secure and maintain market access.
- Provides regulatory advice to other functional areas.
- Identifies perceived gaps in product development plans that may pose regulatory issues.
- Develops and maintains relationships with external vendors (logistics, import/export) and regulatory authorities to improve effectiveness in regulatory strategy execution.
- Oversees regulatory authority inspections and provides input for follow-up to inspections and audits to minimize potential for findings of noncompliance.
- Coordinates preparation of responses to queries from regulatory authorities.
- Coordinates activities pertaining to meetings and conferences with regulatory authorities.
- Oversees activities related to post-market surveillance and ensures compliance with product post-marketing approval requirements.
- Conducts regulatory review of complaints.
- Oversees activities related to product recall and recall communication process.
- Assures medical device reports (MDR) are reported to regulatory agencies and internal stakeholders.
- Manage processes involved with maintaining annual licenses, registrations, listings and patent information.
- Reviews and approves advertising and promotional items to ensure regulatory compliance, including online media and labeling.
- Oversee training of DxTerity employees on regulatory and compliance matters.
- Assures QMS compliance to the QSR, 21 CFR 820, ISO 13485, and any other applicable QMS regulation.
- Other duties, as assigned.
Education and Experience:
- Bachelor’s Degree is required, preferably in a technical discipline such as biology, chemistry, or engineering.
- S. in a technical area or M.B.A. or a Ph.D. in a technical area or law, preferred.
- 7-10 years of relevant industry experience in an FDA regulated environment with a minimum of 5 years in decision-making role.
- Certification (such as RAC from the Regulatory Affairs Professionals Society) preferred.
- Experience in In Vitro Diagnostics, Nucleic Acid-based Chemistry, Molecular Genetics, Gene Expression Platform Analysis, and/or NGS Technologies are a plus.
Qualifications: To perform this job successfully, the candidate must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Demonstrated ability to interpret and stay current with FDA, EU and other regulatory agency regulations and guidelines. International experience is desired.
- Understands the principles and requirements of promotion, advertising and labeling.
- Must demonstrate high-level of motivation to work in a fast-paced, start-up environment.
- Demonstrated ability or track record of achieving successful results in a timely manner.
- Demonstrated ability to be flexible and resourceful with excellent communication and diplomacy skills.
- Organizational, planning and detailed follow-up skills is required. Ability to utilize tasking, scheduling, and other project management tools.
- Leadership and motivational talent needed with ability to relate to both highly educated and unskilled team members.
- Ability to collaborate cross-functionally with several departments.
- Ability to handle and resolve conflicts and work under stressful conditions
- Ability to understand complex scientific, engineering and business concepts.
- Excellent oral and written communication skills.
- Excellent organizational skills and attention to detail.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood-borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Limited travel is required.