Job Description:

At Enovis™ we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence - with the goal of transforming medical technology as we know it.

Because that's how we change the lives of patients for the better. And that's how we create better together.

Job Title:
Regulatory Program Manager
Reports To:
Director, Regulatory Affairs
Location:
Austin (flex - 3 days in office)
Business Unit Description:
Surgical

Role Summary:

We're looking for a highly motivated and self-directed individual to be a Regulatory Program Manager. With minimal direction from Director, Regulatory Affairs, this position is responsible for all activities related to achieving marketing authorizations in the US and in select international markets and in maintaining global regulatory compliance to national and international regulations and standards. This staff member will be responsible for managing all regulatory deliverables for select product lines throughout the product lifecycle from global regulatory strategy development through support of post market activities.

• 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 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, Canada, Australia, Japan, Brazil and China, among others. This includes responding to requests from reviewers and resolving deficiencies in submissions.
• Partnering with Corporate Global Production Registration (GPR) team to coordinate and support select international registrations and maintain existing licenses and certifications through renewals
• Act as regulatory SME during technical documentation audits
• Perform regulatory assessment 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 NCMRs, ensuring changes don't impact safety and effectiveness of products without appropriate regulatory actions being taken
• Review labeling and marketing collateral to ensure compliance with regulations, approval conditions, and consistency of any claims with appropriate data
• 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
• Monitor industry-applicable regulations, guidance, standards, and common specifications for new or modified requirements; support initiatives associated with compliance to new or modified requirements
• Maintain regulatory metrics for reporting to management, monitoring of effectiveness of regulatory processes and ensuring accountability to internal and external stakeholders
• Participates in the review of engineering specifications and quality programs in response to adverse quality levels or return trends.

• Minimum 5 years' experience in medical device regulatory affairs
• Bachelor's degree (engineering, biology, chemistry, or related scientific discipline preferred)
• Advanced degree in engineering or scientific discipline preferred
• RAPS Regulatory Affairs Certification (RAC) preferred
• Proven skills in preparing regulatory submissions in the US and Europe (510(k), De Novo and Technical Documentation). Experience with international regulatory submissions is a plus. Experience with IDE and PMA submissions a plus.
• Thorough knowledge of 21 CFR 820, ISO 13485:2016 and MDSAP requirements
• Expertise in FDA regulations and guidelines
• Expertise in EU MDR requirements
• Familiar with complaint handling, CAPA, Non-conforming material processes, including root cause analysis techniques
• Familiar with using an eQMS system
• Exceptional skills in using computer software and hardware applications, including Microsoft Word and Excel.

• Climate controlled workspace
• Ability to sit or stand for extended periods of time
• While performing the duties of this job, the employee is regularly required to sit and use hands
• Employee must occasionally lift and/or move up to 25 lbs.

• 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