This is a chance to join a global medical devices organization that have been patient-focused for over two decades in the manufacturing of their 1000s of orthopaedic products.
A Lead development opportunity to get on board with the next generation of total joint innovative products with the aim of providing surgeons with even better treatment options.
Remote or relocation package offer to Florida.
Essential Duties and Responsibilities:
- Define targets, KPIs, performance objectives, etc., for individuals within a functional role and manage direct reports to meet or exceed these targets.
- Support direct reports in handling workload within assigned projects through efficient resource utilization and effectively communicate cross-functionally.
- Analyze the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes.
- Assess all requirements and potential obstacles for market access and distribution.
- Critically assess the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations.
- Ensure policies and procedures are in place for appropriate internal review and approval of regulatory submissions.
- Lead key negotiations and interactions with regulatory authorities during all stages of the development and review process.
- Prepare cross-functional teams for interactions with regulatory authorities.
- Lead meetings required to drive closure of regulatory issues.
- Collaborate cross-functionally to create and maintain regulatory related policy, SOPs, and work instructions.
- Collaborate with international regulatory personnel to support global regulatory activities.
- Monitor changes in RA environment and develop and manage programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
Education and Experience:
- Bachelor’s Degree required, preferably in Life Sciences or Engineering.
- Advanced Degree (MS, ME, MBA) preferred.
- Regulatory Affairs (RAC) preferred.
- 10 years direct experience in a Medical Device Regulatory Affairs role required.
- 5 years successful experience in Regulatory Affairs
- Experience in orthopedic medical device industry preferred.
- Experience in independently preparing 510(k) required.
- Experience with FDA or other regulatory agency submission process and regulatory strategy for Class II medical devices required, other regions/ geographies a plus.