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VP, Clinical and Regulatory Affairs
This position serves as a key member of the IRRAS leadership team, leading the Global Regulatory & Clinical Affairs function, and is responsible for the development and execution of global regulatory and clinical affairs strategies. The ideal candidate will have a deep understanding of global regulations that govern medical device approvals and clinical trial study design. This individual should bring to the table an established professional network in the medical community, KOLs, Notified Bodies and FDA. Responsibilities also include identifying and assessing global regulatory risks, while satisfying the role of PRRC (Person Responsible for Regulatory Compliance) as defined in the EU MDR 2017/745 (Medical Device Regulation).
- Spearhead the company’s strategy for securing and maintaining regulatory approval to commercialize its products in markets around the globe
- Support the development of global regulatory agency meeting strategies
- Serve as the global regulatory representative on relevant project teams
- Act as the primary global regulatory contact and perform the duties required of a PRRC, as outlined below, with relevant regulatory authorities
- Support coordination all aspects of global regulatory submission
- Lead and manage the clinical affairs function. This will encompass all aspects of clinical trial management, including budgeting, designing, planning, resource management, institutional review board, legal agreement with sites, purchasing, execution and management of clinical trial protocols, compliance, contracting and data management and analysis of clinical study data.
- Sets the direction, planning, execution and interpretation of clinical trials / research and data collection activities.
- Develops successful clinical protocols for pre-market and post-market studies to drive positive outcomes for clinical trials.
- Provides clinical program management for study activities including statistical analysis for regulatory submissions.
- Conducts site selection, qualification, feasibility assessments, including establishing a business development type relationship with clinical trial sites.
- Collaborates and coordinates with others to design and implement clinical protocols and data collection systems.
- Develops study-related documents and provides direction for the clinical sites to establish protocol development.
- Ensures compliance with/and training for good clinical practices, good documentation practices, and regulatory guidelines, ensuring adherence to domestic and global regulations
RESPONSIBILITIES OF A PRRC: The role of the PRRC is defined in the EU MDR 2017/745, and the person responsible for regulatory compliance shall be responsible for ensuring the following:
|(a)||the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;|
|(b)||the technical documentation and the EU declaration of conformity (DoC) are drawn up and kept up to date;|
|(c)||the post-market surveillance obligations are complied with in accordance with EU MDR 2017/745, Article 10(10); see excerpt below: Post-market surveillance system of the manufacturer 1. For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. That system shall be an integral part of the manufacturer’s quality management system.|
|(d)||the reporting obligations referred to in Articles 87 to 91 are fulfilled. Vigilance Article 87: Reporting of serious incidents and field safety corrective actions Article 88: Trend reporting Article 89: Analysis of serious incidents and field safety corrective actions Article 90: Analysis of vigilance data Article 91: Implementing acts|
|(e)||in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued; see below: A signed statement by the natural or legal person responsible for the manufacture of the investigational device that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject.|
- The person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer’s organization in relation to the proper fulfilment of his or her duties.
- May perform additional duties as assigned or directed by management from time to time
- BA/BS University degree in a related field required.
- A minimum of 7-10 years strategic global regulatory experience, medical device regulatory experience, and seasoned experience in clinical research in the life science field.
- Must understand, follow and comply with regulatory requirements as applicable to various processes. An understanding of FDA Quality System Regulations.
- Ability to manage medical advisory boards and clinical studies.
- Demonstrate excellent communication and influencing skills internally and externally at all levels of the organization.
- Strong interpersonal skills and the ability to deal effectively with a variety of business areas including R&D, quality, compliance, product development, manufacturing, and external partners/collaborators.
- Demonstrate effective cross functional skills including ability to impact industry/agency organization decisions.
- Demonstrate strategic thinking, change agent leadership and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and communicate these effectively and demonstrate optimism and energy in the face of change.
- Ability to work both independently with minimal direction to attain group goals and key project milestones.
- Ability to work closely with those within the Regulatory/Quality departments.
- Demonstrate strong skills to organize, prioritize, and execute.
- Experience in interfacing with relevant global regulatory authorities.
- Experience and knowledge in the preparation of regulatory submissions, registrations, supplements/variations, and amendments.
- Knowledge and understanding of applicable global regulations.
- Experience and knowledge in the medical device industry.
- Performance Orientation – Is driven by personal performance; achieves all objectives detailed in IRRAS Department goals and comfortable with quantifiable assessments.
- Impact Orientation – Performs to stated objectives and driven to make an impact on company goals and patients’ lives.
- Competitive – Dedicated to a competitive spirit that supports the IRRAS goal to be the premier Medical Device company in the industry.
- Sense of Urgency – Has the speed and agility dedicated to the company’s goals and performance.
- Ability to Handle Pressure and Ambiguity – Comfortable with the pressure to be the best and the ability maintain composure and focus in situations of ambiguity and uncertainty.
- Confidence – Confident in one’s skills and abilities; pursues everything with energy; demonstrates the drive and a need to finish especially in the face of resistance or setbacks.
- Multitasking – Capable of performing multiple tasks over a certain period of time by executing them concurrently.
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.
- While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit.
- The employee is occasionally required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. Transition from standing and sitting often.
- Required specific vision abilities might include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- The employee might occasionally lift and/or move up to 10 pounds.
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.
- General office environment.
- Daily exposure to PCs and networks.
- The noise level in the work environment is usually moderate.
- Travel might be required.
The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
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Job posted: 2022-01-03