Senior Regulatory Affairs Specialist

About the role

We are seeking an experienced medical devices regulatory affairs professional to develop and execute regulatory strategies and manage product submissions for enabling technologies in the orthopedic industry. This role will be working on hardware and software as a medical device (SaMD) products for distribution as the Senior RA Specialist.

Responsibilities

• Develop and execute regulatory strategies and manage product submissions for enabling technologies in the orthopedic industry.
• Suggest and lead pre-submission meetings with FDA, Notified Body and TGA as determined to be necessary for select product development pathways.
• Partner closely with clinical affairs in development and execution of clinical strategy and necessary clinical investigations and evaluations related to achieving marketing authorizations.
• Act as regulatory representative on product development teams, providing regulatory input to the PDE/project manager on all facets of regulatory compliance, including but not limited to predicate identification and comparison, verification and validation testing, risk management, standard and common specification conformance, current trends in thinking and decisions by regulatory authorities.
• Execute regulatory strategies by preparing submissions and technical documentation for product approvals in the US, EU, and Australia. This includes responding to requests from reviewers and resolving deficiencies in submissions.
• Partner with Corporate Market Access team to coordinate and support select international registrations and maintain existing licenses and certifications through renewals.
• Perform regulatory assessments on product or process changes and execute necessary actions such as appropriate notifications, new 510ks, letters to file, technical file updates, license amendments, etc.
• Review and approve QMS change orders, design change orders, and NCRs, ensuring changes don’t impact safety and effectiveness of products without appropriate regulatory actions being taken.
• Own and manage specific regulatory-related CAPAs, driving root cause investigation, implementation of actions, and confirming effectiveness.
• Support completion of HHEs and work the Corporate Shared Services team to manage field actions and recalls.
• Maintain regulatory metrics for reporting to management, monitoring effectiveness of regulatory processes and ensuring accountability to internal and external stakeholders.
• Monitor industry-applicable regulations, guidance, standards, and common specifications for new or modified requirements; support initiatives associated with compliance with new or modified requirements.
• Partners with Sales, Operations, and other functions to provide practical QA/RA guidance.
• Review marketing, training, and educational materials to ensure compliance in all geographies.
• Work with cross-functional teams to ensure projects and initiatives meet regulatory and quality requirements.
• Align local RA activities with global policies and standards.

Qualifications, Skills & Experience

• Bachelor’s degree in science, biomedical engineering, regulatory affairs, or a related field.
• 7–8 years’ experience in RA within medical devices, healthcare, or related industry is desirable.
• Proven skills in preparing regulatory submissions in the US, Europe and TGA (510(k), Technical Documentation and Conformity Assessments).
• Experience with international regulatory submissions is a plus.
• Experience in working on products with machine learning and/or artificial intelligence is a plus.
• Expertise in US, EU and TGA regulations, ISO 13485, ISO 14971, and MTAA Code of Practice.
• Ability to work independently within a defined business area while collaborating across a large organization.
• Communicates changes and progress.
• Proactively works to manage competing priorities.
• Analytical – ability to synthesize complex or diverse information and demonstrated ability of attention to detail.
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Uses reason even when dealing with emotional topics.
• Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills.
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Strong ability to influence and persuade.
• Written Communication - Writes clearly and informatively; Varies writing style to meet needs; Able to read and interpret written information.
• Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
• Initiative – self-starter managing day to day tasks and working in collaboration to accomplish deadlines and objectives.
• Business Acumen - Understands business implications of decisions.
• Diversity - Shows respect and sensitivity for cultural differences; Promotes a harassment-free environment.
• Judgement - Exhibits sound and accurate judgment; Includes appropriate people in decision-making process.
• Safety and Security - Observes safety and security procedures; Reports potentially unsafe conditions; Uses equipment and materials properly.
• Demonstrates commitment to the Enovis Values, Mission and Vision.