Job details
****12 months fixed term contract (Hybrid role)****
Key Areas of Responsibility
- Provides regulatory affairs support to the Patient Specific Solutions business to achieve timely approvals of custom devices via custom and compassionate use pathways.
- Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
- Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
- Identifies requirements and potential obstacles for market access distribution.
- Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
Evaluates proposed products for regulatory classification and jurisdiction - Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
- Negotiates with regulatory authorities throughout the product lifecycle
- Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
- Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
- Assists other departments in the development of SOPs to ensure regulatory compliance
- Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
- Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
- Provides regulatory information and guidance for proposed product claims/labeling
- Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
- Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
- Monitors the progress of the regulatory authority review process through appropriate communications with the agency
- Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
- Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees
Education/Work Experience
- BS in Engineering, Science, or related or MSc in Regulatory Science or Clinical Science
- Typically a minimum of 4 years experience
- RAC(s) preferred
Knowledge/Competencies
- Strong project management, writing, coordination, and execution of regulatory items
- Emphasis on technical, clinical and scientific regulatory activities
- Demonstrate knowledge and skills in areas such as regulatory pathways, risk-benefit analysis, communication and collaboration internally and externally, submission, registration, obtaining approval, documentation, compliance, postmarketing surveillance/vigilance and distribution
- Under general supervision, plans, conducts and supervises assignments
- Reviews progress and evaluates results
- Recommends changes in procedures
- Operates with appreciable latitude for unreviewed action or decision
- Reviews progress with management
- May direct work of Specialist or Sr. Specialist
- Seeks out diverse ideas, opinion, and insights and applies them in the workplace
- Connects and relates well with people who think and act differently than oneself
- Embraces scrutiny and accepts feedback as opportunity to learn and improve
- Chooses the best alternative to achieve desired outcome or effect, giving consideration to risks, tradeoffs, timing, and available resources
- Navigates the dynamics, alliances, and competing requirements of the organization or business
- Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities
Posted Date: 02/04/2026
This role will be posted for a minimum of 3 days.
