Senior Regulatory Affairs Specialist

About the Role

As a key member of the Regulatory Affairs team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. 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 focus on hardware and software as a medical device (SaMD) products for distribution as the Senior RA Specialist.

The Senior Regulatory Affairs Specialist is responsible for managing regulatory activities within the United States, European Union, and Australian markets, ensuring compliance with Therapeutic Goods Administration (TGA) regulations, EU MDR, ISO 13485, ISO 14971, 21 CFR 820, and company-wide quality standards. This role will also support sustainable regulatory activities such as postmarket surveillance, regulatory impact assessments, and providing regulatory SME support.

Responsibilities

• Develop global regulatory strategies for new product development initiatives, identifying streamlined and least burdensome pathways for marketing authorization of new or modified products.
• Suggest and lead pre-submission meetings with FDA, Notified Body, and TGA as necessary for select product development pathways.
• Partner closely with clinical affairs in the development and execution of clinical strategy and necessary clinical investigations related to achieving marketing authorizations.
• Act as regulatory representative on product development teams, providing regulatory input on all facets of compliance, including predicate identification, verification and validation testing, risk management, and standard conformance.
• Execute regulatory strategies by preparing submissions and technical documentation for product approvals in the US, EU, and Australia, including responding to reviewer requests and resolving deficiencies.
• Partner with the Corporate Market Access team to coordinate and support international registrations and maintain existing licenses and certifications through renewals.
• Act as regulatory SME during technical documentation audits.
• Perform regulatory assessments on product or process changes and execute necessary actions such as notifications, new 510(k)s, letters to file, and technical file updates.
• Review and approve QMS change orders, design change orders, and NCRs, ensuring changes don’t impact product safety and effectiveness without appropriate regulatory actions.
• Review labeling and marketing collateral to ensure compliance with regulations and approval conditions.
• Own and manage specific regulatory-related CAPAs, driving root cause investigation and implementation of actions.
• Support completion of HHEs and work with the Corporate Shared Services team to manage field actions and recalls.
• Monitor industry-applicable regulations, guidance, standards, and common specifications for new or modified requirements.
• Maintain regulatory metrics for reporting to management, monitoring effectiveness of regulatory processes.
• Participate in the review of engineering specifications and quality programs in response to adverse quality levels or return trends.
• Partner 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.

Requirements

• Bachelor’s degree in science, biomedical engineering, regulatory affairs, or a related field.
• 5+ years’ experience in medical devices, healthcare, or related industry.
• 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.
• Strong analytical skills with the ability to synthesize complex or diverse information and demonstrated attention to detail.
• Problem-solving skills to identify and resolve issues in a timely manner.
• Excellent oral and written communication skills.
• Commitment to quality management and continuous improvement.
• Self-starter with the ability to manage day-to-day tasks and collaborate to meet deadlines.
• Business acumen to understand the implications of decisions.
• Emotional intelligence to navigate conflict and maintain professionalism during stress.
• Respect for diversity and promotion of a harassment-free environment.
• Sound judgment and ability to include appropriate people in the decision-making process.
• Commitment to safety and security procedures.

Working Conditions

• Primarily office environment.
• Occasional travel to manufacturing sites, clinical validation sites, and surgeon workshops.
• Hands-on interaction with surgical instruments, navigation hardware, and integrated testing environments.

Benefits

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Spending and Savings Accounts
• 401(k) Plan
• Vacation, Sick Leave, and Holidays
• Income Protection Plans
• Discounted Insurance Rates
• Legal Services

Currently, Enovis does not provide sponsorship for employment visas (e.g., H-1B) and will not offer such sponsorship in the future. Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.