Regulatory Affairs Specialist
Regulatory Affairs Specialist
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Salary Not Disclosed
1 Vacancy
Job Description
Job Description:
At Enovis we pay attention to the details. We embrace collaboration with our partners and patients and take pride in the pursuit of scientific excellence with the goal of transforming medical technology as we know it.
Because thats how we change the lives of patients for the better. And thats how we create better together. Why work at Enovis See for yourself.
Job Title:
Regulatory Affairs Specialist
Reports To:
Director Regulatory Affairs Foot & Ankle
Location:
Atlanta GA or Houston TX
Business Unit Description:
Regulatory Affairs
High-Level Position Summary:
We are seeking a skilled and experienced Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist will be supporting a wide range of regulatory activities to ensure compliance with global submission requirements departmental processes and quality system standards. This role will develop regulatory strategies complete impact assessments and prepare submissions including U.S. FDA 510(k)s EU MDR Technical Documentation and other OUS registrations. The RA Specialist will support the Foot & Ankle Business Unit (F&A BU) contribute to new product development and sustaining projects and engage with global regulatory authorities including the FDA and EU Notified Body.
Key Responsibilities
The following are the primary duties and responsibilities of this role. Other related duties may be assigned to meet the business need.
- Provide regulatory expertise and guidance to cross-functional teams for both new product development and sustaining projects.
- Complete regulatory deliverables for assigned projects including strategy development impact assessments and submission preparation through to clearance or approval.
- Prepare global submissions including but not limited to U.S. FDA 510(k) Premarket Notifications PMA submissions EU MDR Technical Documentation and other international product registrations
- Collaborate with cross-functional teams to collect and review technical documentation ensuring accuracy regulatory compliance and timely submissions.
- Communicate and negotiate with global regulatory bodies during submission reviews audits and post-market activities.
- Identify risks and develop contingency plans for assigned regulatory projects.
- Interpret and communicate regulatory requirements and guidance to internal teams and stakeholders.
- Maintain regulatory databases trackers and documentation in accordance with internal procedures and applicable regulations.
- Support compliance-related activities such as site registrations audits and post-market surveillance (e.g. HHEs MDRs FAs CAPAs).
- Apply quality system knowledge to all job functions.
- Perform additional tasks as assigned by the Regulatory Manager.
- Comply with Enoviss Code of Conduct company policies procedures and standards.
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.
Minimum Basic Qualifications:
- Bachelors degree in a scientific discipline (e.g. biology microbiology chemistry engineering or medical technology).
- Minimum 5 years of regulatory affairs experience in the medical device industry.
- Proven experience preparing U.S. FDA 510(k) submissions.
- Strong understanding of design and change control processes regulatory assessments and quality system requirements under ISO 13485 and FDA QSR.
- Experience working cross-functionally and with regulatory agencies.
Desired Characteristics:
- Experience with international registrations and submissions including EU MDR.
- Knowledge of medical device labeling and associated regulations.
- High attention to detail with a focus on accuracy and completeness.
- Strong written and verbal communication skills.
- Excellent organizational planning and time management abilities.
- Analytical and problem-solving mindset.
- Strong interpersonal and team collaboration skills.
- Ability to work independently with minimal supervision.
- Adaptable proactive and capable of leading regulatory initiatives.
- Proficient in Microsoft Office Adobe Acrobat and Agile PLM systems.
Travel: 10%
Work environment Physical demands:
Ability to sit and stand for long periods of time.
Work schedule:
Hybrid schedule is available with three days on-site.
Creating better together. Its the Enovis purpose and its what drives us and empowers us every day on a global scale. We know that the power to create better for our customers our team members and our shareholders begins with having the best team pursuing common goals operating at the highest levels and delivering extraordinary outcomes.
Watch this short on creating the next generation of better together at Enovis:
We offer a comprehensive benefits package which includes:
- 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
ABOUT ENOVIS
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement global talent and innovation the Companys extensive range of products services and integrated technologies fuels active lifestyles in orthopedics and beyond. Visit to learn more.
EQUAL EMPLOYMENT OPPORTUNITY:
Enovis provides equal employment opportunities based on merit experience and other work-related criteria and without regard to race color ethnicity religion national origin sex age pregnancy disability veteran status or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.
ABOUT ENOVIS
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement global talent and innovation the Companys extensive range of products services and integrated technologies fuels active lifestyles in orthopedics and more information about Enovis please visit .
EOE AA M/F/VET/Disability Statement
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race religion color national origin sex protected veteran status disability or any other basis protected by federal state or local laws.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
