Job Details

Pay 55-64 depending on experience
 

HM’s Top Needs:

1. Conduct Global Regulatory Change Assessment 

2. US Letter-to-file and EU Technical Documentation 

3. Review verification and validation test protocol and reports 

• Supports change control activities to support global approval and implementation of product and process changes.
• Leads or compiles all materials required in CE-Mark and FDA submissions, internal regulatory documentations, license renewal and annual registrations.

• Teams with other business unit Regulatory Affair Specialists and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
• Recommends changes for labelling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance.

Education Required: B.S. In Engineering or Science

Years’ Experience Required:

10 years medical device regulatory affairs experience 

               
Responsibilities may include the following and other duties may be assigned.

• Develop and implement regulatory strategies for new products, product changes, and lifecycle activities.
• Assess regulatory pathways and requirements for U.S. and EU markets.
• Prepare, review, and submit high-quality regulatory submissions such as:
  • 510(k)s
  • Technical documentation
  • Letter-to-file 
• Provide regulatory guidance to cross-functional teams including R&D, Quality, Clinical, Medical Affairs, Marketing, Operations, and Legal.
• Interpret applicable regulations, guidance documents, and standards to ensure compliance.
• Support product development teams by identifying regulatory risks and recommending mitigation plans.
• Represent Regulatory Affairs in design reviews, risk management activities, change control, and product lifecycle decisions.
• Interface with regulatory authorities, notified bodies, and other external agencies as needed.
• Support audits, inspections, and responses to regulatory questions or deficiencies.
• Review promotional, labeling, and product change materials for regulatory impact.
• Monitor emerging regulations and communicate business impact to stakeholders.
• Mentor junior regulatory professionals and contribute to department process improvements.

SPECIALIST CAREER STREAM:
– Typically an individual contributor with responsibility in a professional discipline or specialty.
– Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
– May act as a mentor to colleagues or may direct the work of other lower level professionals.
– The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS Autonomy:
– Recognized expert, managing large projects or processes .
– Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager .
 – Coaches, reviews and delegates work to lower level specialists.

Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results . May manage large projects or processes that span outside of immediate job area.

Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation . Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems.

Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels . May negotiate with others to reach understanding or agreement, and influence decisionmaking.

Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.

Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.