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Purpose of the Position: The Manager – RA will be specifically responsible for the regulatory tactical plans based on the established regulatory strategy. This position will review and approve the technical content provided by R&D of all regulatory submissions and registrations for the OMD business even though the in country registrations may be assigned to others for filing. In addition the Manager – RA will support the Clinical and Regulatory Compliance activities, by providing regulatory support for all OMD projects developed under the OMD design controls for the OMD products are adequate within the site quality systems which meet/exceed domestic FDA international standards and regional regulations (i.e. CE marking).
Essential Duties and Responsibilities: The Manager – RA will develop regulatory tactical plans for the specific product categories and be responsible for its implementation and documentation within the project plan. He/she will work on a team basis with his/her counterparts to ensure the highest standards are achieved. Verification and validation studies will be reviewed to comply with all regulatory guidelines, yet through design and accuracy, secure the greatest probability of expedited approvals using the least burdensome approach. The Manager – RA will work closely with regulatory agencies to ensure that the company is in compliance with all applicable laws. The candidate will be familiar with the Regulatory agencies and processes in major regional markets. This individual will work collaboratively with other functional leaders to identify and select well-recognized and respected clinical investigators, and provide leadership and direction to ensure protocol compliance and timely completion of studies. The Manager –RA will be responsible for thedevelopment of the strategic and tactical plans for OMD products which will lead to the most expedient method of approval for regulatory submissions (i.e. 510k in USA) and other international regulated markets. As business conditions dictate, he/she may also be required to develop an effective PMA submission methodology.
Under direction of the OMD VP-Quality & Regulatory Affairs, the Manager – RA will provide regulatory support for new projects arising as a result of acquisitions by or restructuring within Osmetech.
This position will interface with Corporate Executive Management, Commercial and Site Management, Government Agencies, Investigational Review Boards (IRB), R&D/Marketing/Operations/Quality, customers, clinical monitors, medical advisors, and consultants. As a member of the project team, this individual will collaborate to define business strategy and have a strong voice in overall direction and risk management decisions.
Supervisory Responsibilities:
Qualifications: To perform this job successfully, an individual 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.
This selected candidate will have intellectual depth and strength of character as primary attributes. Moreover, this individual will possess outstanding communication skills and will be clear and concise in all forms of communication, as well as be able to articulate clear requirements and expectations for the Regulatory Affairs function.
The ideal candidate will have a well-rounded mix of experience in IVD and/or medical device companies. The successful candidate will possess a diverse network of individuals to consult when critical decisions require third-party perspectives. This position requires a hands-on, experienced leader who communicates well at all levels.
Essential competencies include: the ability to build and lead teams towards completion of imperative milestones; the ability to establish credibility with a broad range of constituents inside and outside the company; creative problem-solving skills and the willingness to take risks and act decisively, yet communicate potential consequences to enable informed business decisions; steadfast leadership that can be counted on in both good and challenging times; self confidence and a readiness to stand up for beliefs balanced by the maturity to maintain appropriate level of flexibility; ability and willingness to “roll up the sleeves” and become actively engaged in tactical execution; be recognized and respected by key decision-makers within regulatory agencies; be a driven leader with a sustained high energy level; be an independent worker driven to succeed who is unflappable in challenging situations; the ability to develop the strategic and tactical plans for Regulatory Affairs; and an individual with well-rounded business acumen who is capable of making contributions outside of functional expertise. He/she must be comfortable in international settings and can work with multi-national teams. He/she will demonstrate exceptional communication and team building skills in a variety of locations and amongst different nationalities. Must be capable and willing to travel domestically and internationally as the business needs. Must be capable of obtaining a US Passport.
In addition, the Manager – RA will be able to design, conduct and report on clinical studies; audit and investigate design controls management processes; have experience with complaints and adverse events reporting, investigation, and of preventive and corrective action programs; and have knowledge and experience in post marketing surveillance and MDR/Vigilence reporting.
Education and Experience: This individual must possess a Bachelor degree, preferable in the Life Sciences, Medical/Clinical or Science of Engineering fields; graduate degrees and/or RAC being preferred. The Manager – RA will have a minimum of five years of experience in Regulatory/Clinical Affairs for USA and international markets. The individual will have a comprehensive working knowledge of U.S. FDA regulations and procedures for 510k and PMA medical devices. He/she will understand the need for current Quality System/GMP/ISO compliance. Experience and knowledge with regulatory agencies and processes in USA and international markets is required, and a proven track record of submissions and approvals with regulatory agencies is necessary. This candidate will have earned the respect and credibility of key decision makers within the various global regulatory bodies through multiple previous interactions.
Language Skills: Must be proficient in writing, and communicating in the English language.
Mathematical Skills: Must be consistent with claimed level of education. Knowledge of and practical experience with statistics is desirable.
Reasoning Ability: Good problem solving, judgment and decision making skill are required.
Certifications, Licenses, Registrations: None needed
Physical Demands: 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. Work occasionally requires travel between buildings. This is typically completed by foot or by car.
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.
Work Environment: 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-bourne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
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