Regulatory Affairs Specialist - Medical Device

Regulatory Affairs Specialist - Medical Device

The Regulatory Specialist will be a part of the Company AMEA R&D organization and supports the various R&D projects. The role will involve working closely with the multiple cross functional stakeholders i.e. Global, Regional and in country RA, Global & AMEA R&D, and other stakeholders. This role will have a matrix reporting to Director AMEA R&D and Director / VP of Global RA.

This entails identifying regulatory requirements for the product launch markets and working closely with the Project Manager, R&D leads and larger R&D team to ensure all regulatory requirements are incorporated into the product development cycle. The individual will also be responsible for providing technical requirements into the Risk Management, Design Quality and Verification and validation phase of the product development and fulfill all documentation requirements for the product for submission in various markets. The individual will be working with Global BU specific Regulatory Specialists to prepare adequate documentation and providing regular feedback on the same.

This individual will also be responsible to build the RA capabilities, processes and documentation framework for all the projects executed at the AMEA site and will be the point person for all RA requirements for the global teams.

The candidate needs to be a self-motivated individual skilled in leading requirements analysis, documenting the requirements, understanding the Regulatory framework in AMEA region

This role is a part of an R&D team and will be a part of the site R&D leadership team. The role however does not have an external facing responsibility with regulatory bodies. The individual may be required to work with external regulatory bodies only on a need basis and on request from the global, regional or in-country RA leads.

Key Responsibilities

- Work as a core team member of the AMEA R&D project teams.

- Work with corporate Regulatory to identify applicable SOPs; train R&D team to those SOPs.

- Establish communication with the corresponding divisional RA resource and keep them appraised of development progress and any challenges

- Identify regulatory requirements applicable to target launch markets; collaborate in developing a regulatory strategy for those launch markets

- Work with launch market RA resources to ensure required documentation is being developed and to the required quality and level of detail

- Provide feedback to team on adequacy of documentation to meet regulatory registration needs

- Post product launch, work with divisional RA resource and country RA representatives to evaluate proposed product changes

- Develop regulatory submission documents, arrange for Reviews and edits submissions.

- Provide inputs in concept selection, project planning, regulatory challenges during business case development.

- Participate in Design Input, risk management, design output and verification and validation phase of product development and provide requirements into each phase.

- Responsible for developing regulatory documents along the entire development phase and ensure compliance to global RA SOP's.

- Represents Regulatory Affairs at management updates.

- Support and maintain Quality initiatives in accordance with BSC Quality Policy.

- Provides Regulatory Affairs training/mentoring to other employees.

- Oversees preparation and submission of global regulatory applications as appropriate as well as internal regulatory file documentation.

Qualifications:

- Bachelors or Masters degree in Engineering of Science.

- Post Graduate or Certification or Post Diploma in medical device Regulatory affairs or RAPS certification or equivalent.

- 5 - 8 years of experience in RA function for Class II/ III medical device or drug delivery products.

- Sound understanding of regulatory requirements for key markets / countries like USA, Japan, China, India, Europe.

- Needs strong understanding of US FDA, CE, ISO 13495 quality systems, ISO 14971 Risk management.

- Needs to be well versed with R&D product development processes and RA requirements during the development cycle.

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

For those individuals that supervise others, the following statements are applicable:

- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.

- Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Management Requirements

- Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.

- Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).

Job Scope and Leveling Guidelines

Job Complexity

Works on issues of moderate scope where analysis of situations or data requires evaluation of a variety of factors, including an understanding of current business trends. Must have a complete understanding of functional specialty and industry practices, techniques, and standards. Follows processes and operational policies in selecting methods and techniques for obtaining solutions. Acts as an advisor to subordinates to meet schedules and/or resolve technical problems. Develops and administers schedules and performance requirements. May have budget responsibilities.

Policy Involvement :

- Interprets and executes policies and procedures that typically affect subordinate organizational units. Recommends modifications to operating policies. Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned area or related departments.

Operations Involvement/Direct Work Involvement :

- Functions as an advisor to a unit regarding tasks, projects, and operations. Investigates and solves problems that impact work processes and personnel within the assigned unit. Becomes actively involved in daily operations only when required to meet schedules or to resolve complex problems.

Project Involvement :

- Manages projects of small to moderate scope including schedules, scope, costs and resources. May participate in cross-function teams.

Planning and Organization :

Creates immediate to mid-range plans to carry out objectives established by top management. Schedules human and material resources within a group or section in conjunction with plans to ensure their availability; carries out operations within an established budget.

Impact :

- Assignments are expressed in the form of tasks and objectives; generally makes day-to-day decisions within established guidelines regarding work processes or schedules in order to achieve the program objectives established by senior management. Ensures that projects are completed on schedule and within budget. Erroneous decisions or recommendations or failure to complete assignments would normally result in serious delays to assigned projects resulting in considerable expenditure of additional time, human resources, and funds.

- The above statements are intended to describe the general nature and level of work being performed by people 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.

Team - HR