Regulatory Affairs Specialist

3 months ago

Austin, United States Enovis Full time

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 Affairs Specialist

Reports To:

Director, Regulatory Affairs | Surgical

Location:

Austin Plant

Business Unit Description:

Regulatory Affairs

Role Summary:

We are seeking a skilled and experienced Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist will work with supervision to bring new and modified medical devices to market and ensure ongoing compliance. The Regulatory Affairs Specialist will be the regulatory representative on product development teams and will be responsible for developing regulatory strategies, authoring submissions, and assessing design and manufacturing changes for wide range implantable products.

Key Responsibilities: The following are the primary duties and responsibilities of this role. Other related duties may be assigned to meet the business need. 

Acts as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product development cycle.

Develops and executes regulatory strategies for new and modified products.

Works with regulatory and cross-functional peers to resolve potential regulatory/technical issues and questions from the regulatory agencies.

Manages the release and shipment of products under regulatory controls to all regions.

Provides recommendations for how to overcome regulatory barriers and resolve any disputes within teams as to the importance of regulatory requirements.

Coordinates and prepares regulatory submissions for new and modified products ensuring compliance with applicable regulatory requirements and company policies.

Handles the preparation and processing of documentation required for new product introductions and revised products in international markets.

Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations.

Provides technical guidance and regulatory training to cross-functional teams.

Reviews device labeling and advertising materials for compliance with applicable regulations and recommends appropriate changes.

Monitor the development of new regulatory requirements and advise of the impact to cross-functional teams.

Develops and maintains procedures to ensure compliance and support business goals.

Maintains proficiency in government regulations and guidances.

Support other regulatory requests or projects as needed.

Minimum Basic Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Bachelor’s degree with a minimum of 2 years of medical device industry experience

Prior experience with regulatory submissions, such as PMA or 510(k)

Working knowledge of FDA and international regulations for medical devices

General understanding of the product development process and design controls

Ability to manage several projects simultaneously

Strong interpersonal and influencing skills

Ability to independently manage projects, prioritize time and communicate effectively

Work environment | Physical demands:

Ability to sit and stand for long periods of time.

“Creating better together”. It’s the Enovis purpose, and it’s 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 InsuranceDental InsuranceVision InsuranceSpending and Savings Accounts401(k) PlanVacation, Sick Leave, and HolidaysIncome Protection PlansDiscounted Insurance RatesLegal Services

ABOUT ENOVIS

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™

EOE AA M/F/VET/Disability Statement

  • Regulatory Affairs Specialist

    3 weeks ago

    Austin, United States Enovis Full time

    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...

  • Regulatory Affairs Specialist III – Diabetes Care Lead

    1 week ago

    Austin, Texas, United States Abbott Laboratories Full time

    Unlock Your Potential in Regulatory AffairsWe are seeking a highly skilled Regulatory Affairs Specialist III to join our team at Abbott Laboratories. As a key member of our Diabetes Care Division, you will play a critical role in ensuring the quality and regulatory compliance of our products.About the Role:This is an exciting opportunity to work on-site in...

  • Regulatory Affairs Specialist III – Global Compliance Expert

    2 hours ago

    Austin, Texas, United States Abbott Laboratories Full time

    At Abbott Laboratories, we're committed to improving the quality of life for people around the world. As a Regulatory Affairs Specialist III in our Diabetes Care Division, you'll play a crucial role in ensuring our products meet regulatory requirements and are brought to market efficiently.As part of our team, you'll be responsible for executing regulatory...

  • Regulatory Operations Specialist

    1 week ago

    Austin, Texas, United States JSI Full time

    Job OverviewWe are seeking a highly skilled Regulatory Operations Specialist to join our Regulatory Affairs Department.Key ResponsibilitiesManage and maintain JSI's web-based regulatory tracking tool, ensuring clients' risk mitigation and compliance requirements are met.Coordinate project delivery within specified scope and budget, ensuring timely...

  • State Government Affairs Specialist

    7 days ago

    Austin, Texas, United States Constellation Full time

    About UsWe are Constellation, a leading competitive energy provider with a strong presence in the nation's energy market. Our team of outstanding professionals is dedicated to delivering high-quality power generation, sales, and delivery services.Job SummaryWe are seeking a highly motivated State Government Affairs Intern to join our team in Austin, TX. This...

  • Senior Corporate Affairs Specialist

    1 month ago

    Austin, United States CINTRA US SERVICES LLC Full time

    Who is Cintra?Cintra is the highways business unit of Ferrovial, one of the world's leading infrastructure operators committed to developing sustainable solutions. Ferrovial is listed simultaneously on 3 stock markets: USA (Nasdaq), the Netherlands (Euronext Amsterdam), and Spain (IBEX 35). Ferrovial U.S. listing represents a key step in its...

  • Energy Regulatory Specialist

    1 week ago

    Austin, Texas, United States Balch & Bingham LLP Full time

    Key HighlightsWe are seeking highly skilled Energy Regulatory Specialists to join our Austin, TX office.Estimated Annual Salary: $180,000 - $250,000About the RoleOur team at Balch & Bingham LLP is a globally ranked energy team that requires specialists with 1-4 years of law firm or federal agency experience in energy regulatory, nuclear, and related...

  • External Affairs Strategist

    6 days ago

    Austin, Texas, United States Central Health Full time

    About Central HealthCentral Health is a leading healthcare organization dedicated to improving the health and well-being of our community. We are seeking a highly skilled External Affairs Specialist to join our team.

  • Marketing Regulatory Specialist

    2 hours ago

    Austin, Texas, United States Hunt Hive Talent Full time

    Marketing Regulatory SpecialistWe are seeking a Marketing Regulatory Specialist to join our team. This position offers an exceptional opportunity to work with businesses across various industries, providing strategic legal guidance on innovative marketing initiatives while navigating complex regulatory frameworks.In this role, you will play a pivotal role in...

  • Regulatory Compliance Specialist

    3 days ago

    Austin, Texas, United States JSI Full time

    Job OpportunityWe are seeking a highly motivated Regulatory Compliance Specialist to join our team at JSI. This role will be based in either Greenbelt, MD or Austin, TX.About the RoleThis position supports multiple functions within our organization, including regulatory reporting, client and business development, and operational excellence.Regulatory...

  • Energy Regulatory Compliance Specialist

    7 days ago

    Austin, Texas, United States Hunt Hive Talent Full time

    Job OverviewWe're seeking a highly skilled Energy Regulatory Compliance Specialist to join our esteemed clients in their Austin, TX office. This role is ideal for legal professionals with expertise in regulatory and compliance matters within the energy sector.About UsHunt Hive Talent Recruiting Agency builds bridges to success by connecting talent with...

  • Associate Director of Legal Affairs

    1 month ago

    austin, United States Texas Association of Community Health Centers (TACHC) Full time

    Job SummaryThe Associate Director of Legal Affairs: provides support to ensure that TACHC achieves its mission to strengthen and support community health centers to speak with a unified voice and drive healthcare transformation by exemplifying innovation, access and equity; assists the Director of Legal Affairs to provide in-house counsel as well as advice...

  • Associate Director of Legal Affairs

    4 weeks ago

    austin, United States Texas Association of Community Health Centers (TACHC) Full time

    Job SummaryThe Associate Director of Legal Affairs: provides support to ensure that TACHC achieves its mission to strengthen and support community health centers to speak with a unified voice and drive healthcare transformation by exemplifying innovation, access and equity; assists the Director of Legal Affairs to provide in-house counsel as well as advice...

  • Associate Director of Legal Affairs

    4 weeks ago

    Austin, United States Texas Association of Community Health Centers (TACHC) Full time

    Job SummaryThe Associate Director of Legal Affairs: provides support to ensure that TACHC achieves its mission to strengthen and support community health centers to speak with a unified voice and drive healthcare transformation by exemplifying innovation, access and equity; assists the Director of Legal Affairs to provide in-house counsel as well as advice...

  • Associate Director of Legal Affairs

    1 month ago

    Austin, United States Texas Association of Community Health Centers (TACHC) Full time

    Job SummaryThe Associate Director of Legal Affairs: provides support to ensure that TACHC achieves its mission to strengthen and support community health centers to speak with a unified voice and drive healthcare transformation by exemplifying innovation, access and equity; assists the Director of Legal Affairs to provide in-house counsel as well as advice...

  • Corporate M&A Compliance Specialist

    5 days ago

    Austin, Texas, United States SPS PoolCare Full time

    Job OverviewWe are seeking a highly skilled Corporate M&A Compliance Specialist to join our team at SPS PoolCare in Austin, TX.Estimated Salary: $60,000 - $80,000 per yearThis is a full-time position that requires a strong background in corporate transactions, regulatory affairs, and transactional matters.About the RoleThe ideal candidate will have...

  • Legal Assistant

    2 months ago

    austin, United States Naman Howell Smith & Lee, PLLC Full time

    The Austin office of Naman, Howell, Smith & Lee, PLLC, an established, over 100-year-old Texas law firm has an immediate opening for a legal assistant with at least 2 years of relevant legal experience to assist a growing office. This career opportunity will require assisting with regulatory matters as well as a wide range of business matters, including...

  • Legal Assistant

    2 months ago

    Austin, United States Naman Howell Smith & Lee, PLLC Full time

    The Austin office of Naman, Howell, Smith & Lee, PLLC, an established, over 100-year-old Texas law firm has an immediate opening for a legal assistant with at least 2 years of relevant legal experience to assist a growing office. This career opportunity will require assisting with regulatory matters as well as a wide range of business matters, including...

  • Legal Assistant

    2 months ago

    austin, United States Naman Howell Smith & Lee, PLLC Full time

    The Austin office of Naman, Howell, Smith & Lee, PLLC, an established, over 100-year-old Texas law firm has an immediate opening for a legal assistant with at least 2 years of relevant legal experience to assist a growing office. This career opportunity will require assisting with regulatory matters as well as a wide range of business matters, including...

  • Legal Assistant

    2 months ago

    Austin, United States Naman Howell Smith & Lee, PLLC Full time

    The Austin office of Naman, Howell, Smith & Lee, PLLC, an established, over 100-year-old Texas law firm has an immediate opening for a legal assistant with at least 2 years of relevant legal experience to assist a growing office. This career opportunity will require assisting with regulatory matters as well as a wide range of business matters, including...