The Sr Manager, Regulatory Affairs provides strategic leadership for and oversight of the Lifecycle (Postmarket) Regulatory team accountable for Advita's postmarket regulatory affairs, i.e ...
19 Exactech Regulatory Affairs Manager Jobs Hiring Near You
The Sr Manager, Regulatory Affairs provides strategic leadership for and oversight of the Lifecycle (Postmarket) Regulatory team accountable for Advita's postmarket regulatory affairs, i.e ...
$57.75 - $74.25/hr
... Affairs, External Customers and other key stakeholders. * Establish an overall clinical data ... Develop and promote data management methodologies and standards, that are within regulatory ...
Quick apply
$57.75 - $74.25/hr
... Affairs, External Customers and other key stakeholders. * Establish an overall clinical data ... Develop and promote data management methodologies and standards, that are within regulatory ...
Senior Quality Engineer, Validation
Gainesville, FL · On-site
$80K - $108K/yr
Identify and communicate significant quality and compliance concerns to the Mgr. Validations, QA and associated project team leaders early in the V&V development phase. * Informs Regulatory Affairs ...
Senior Quality Engineer, Validation
Gainesville, FL · On-site
$80K - $108K/yr
Identify and communicate significant quality and compliance concerns to the Mgr. Validations, QA and associated project team leaders early in the V&V development phase. * Informs Regulatory Affairs ...
Partner with Engineering, Operations, Supply Chain, Quality, Regulatory, Finance, and Procurement ... Project Management Professional (PMP) certification preferred. Experience: * Minimum of 6-8 years ...
Partner with Engineering, Operations, Supply Chain, Quality, Regulatory, Finance, and Procurement ... Project Management Professional (PMP) certification preferred. Experience: * Minimum of 6-8 years ...
We also manage profitability and cash flow for all product lines For the Foot & Ankle product Line ... Provide field education and assist with follow up on regulatory issues. * Support the selling ...
New
We also manage profitability and cash flow for all product lines For the Foot & Ankle product Line ... Provide field education and assist with follow up on regulatory issues. * Support the selling ...
New
Product Manager, Knee
Gainesville, FL · On-site
We also manage profitability and cash flow for all product lines. For the Product Line: * Assist in ... Provide field education and assist with follow up on regulatory issues. * Support the selling ...
Product Manager, Knee
Gainesville, FL · On-site
We also manage profitability and cash flow for all product lines. For the Product Line: * Assist in ... Provide field education and assist with follow up on regulatory issues. * Support the selling ...
The Associate Product Manager supports this by understanding our customers' needs through direct ... Provide technical product support to agents, representatives, and surgeons * Assist with regulatory ...
The Associate Product Manager supports this by understanding our customers' needs through direct ... Provide technical product support to agents, representatives, and surgeons * Assist with regulatory ...
The Manager, Quality Engineering, provides leadership to the Quality Engineering team by inspiring ... Quality & Regulatory Compliance: Ensure alignment with FDA, ISO 13485, MDSAP, EU MDR, and internal ...
The Manager, Quality Engineering, provides leadership to the Quality Engineering team by inspiring ... Quality & Regulatory Compliance: Ensure alignment with FDA, ISO 13485, MDSAP, EU MDR, and internal ...
QA PM Specialist
Gainesville, FL · On-site
Submits regulatory reports to FDA or Regional Competent Authority within regulatory timeframes. * Escalates high severity events and cases to Management. * Supports the completion of complaint ...
QA PM Specialist
Gainesville, FL · On-site
Submits regulatory reports to FDA or Regional Competent Authority within regulatory timeframes. * Escalates high severity events and cases to Management. * Supports the completion of complaint ...
... regulations * Learns to advocate on behalf of your customers across Advita leveraging management as appropriate to highlight and resolve issues. * Learns to identify and highlight pricing ...
... regulations * Learns to advocate on behalf of your customers across Advita leveraging management as appropriate to highlight and resolve issues. * Learns to identify and highlight pricing ...
The Quality Systems Engineer, Senior is a top-level leader, developing and supporting the company's Quality Management Systems, ensuring adherence to domestic and international regulations and ...
The Quality Systems Engineer, Senior is a top-level leader, developing and supporting the company's Quality Management Systems, ensuring adherence to domestic and international regulations and ...
VP IT
Gainesville, FL · On-site
$142K - $178K/yr
Establish and maintain enterprise standards for architecture, software development, cybersecurity, risk management, business continuity, disaster recovery, and regulatory compliance to protect ...
VP IT
Gainesville, FL · On-site
$142K - $178K/yr
Establish and maintain enterprise standards for architecture, software development, cybersecurity, risk management, business continuity, disaster recovery, and regulatory compliance to protect ...
CMM Programmer
Gainesville, FL · On-site
... regulatory and quality system requirements. * Develop, validate, and maintain CMM inspection programs and measurement routines. * Manage program revisions and maintain inspection software ...
CMM Programmer
Gainesville, FL · On-site
... regulatory and quality system requirements. * Develop, validate, and maintain CMM inspection programs and measurement routines. * Manage program revisions and maintain inspection software ...
... regulations * Learns to advocate on behalf of your customers across Advita leveraging management as appropriate to highlight and resolve issues. * Learns to identify and highlight pricing ...
... regulations * Learns to advocate on behalf of your customers across Advita leveraging management as appropriate to highlight and resolve issues. * Learns to identify and highlight pricing ...
... regulatory requirements, internal policies, and business objectives. Commercial Contracts & Business Transactions * Lead drafting, review, negotiation, and lifecycle management of a broad range of ...
... regulatory requirements, internal policies, and business objectives. Commercial Contracts & Business Transactions * Lead drafting, review, negotiation, and lifecycle management of a broad range of ...
IT Support Engineer
Gainesville, FL · On-site
Lead problem management efforts, identifying trends and addressing systemic issues. * Partner with ... Ensure compliance with quality systems, security standards, and regulatory requirements. Education:
New
IT Support Engineer
Gainesville, FL · On-site
Lead problem management efforts, identifying trends and addressing systemic issues. * Partner with ... Ensure compliance with quality systems, security standards, and regulatory requirements. Education:
New
... in compliance with applicable regulatory and quality system requirements. * Act as the ... Maintain accurate documentation in accordance with document control and change management ...
... in compliance with applicable regulatory and quality system requirements. * Act as the ... Maintain accurate documentation in accordance with document control and change management ...
Design Engineer, Packaging
Gainesville, FL · On-site
$123K/yr
Areas of involvement include regulatory submissions, Design History Files, package/case evaluation ... management, orthopedic implants and/or instruments and the materials and methods used in their ...
Design Engineer, Packaging
Gainesville, FL · On-site
$123K/yr
Areas of involvement include regulatory submissions, Design History Files, package/case evaluation ... management, orthopedic implants and/or instruments and the materials and methods used in their ...
It is not a regional sales management role; its focus is expanding the company's access to talent ... Maintain a working knowledge of applicable legal and regulatory requirements affecting the ...
Posted today
It is not a regional sales management role; its focus is expanding the company's access to talent ... Maintain a working knowledge of applicable legal and regulatory requirements affecting the ...
Posted today
Exactech Jobs Information
Do workers at Exactech get paid breaks?
Sometimes. Only some people get paid breaks.
40% of people say they don’t get paid breaks.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and March 2026.
40% of people say they don’t get paid breaks.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and March 2026.
Does Exactech pay people when they’re sick?
Sometimes. Only some people get paid when they’re sick.
40% of people say they wouldn’t get paid if they were sick but scheduled to work.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and August 2025.
40% of people say they wouldn’t get paid if they were sick but scheduled to work.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and August 2025.
Do Exactech workers get to choose the shifts they work?
Some people don’t get to choose which shifts they work.
60% report that they don’t have enough control over which shifts they work.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and August 2025.
60% report that they don’t have enough control over which shifts they work.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and August 2025.
How easy is it to get time off at Exactech?
Most people find it easy to get time off.
67% of people report it’s easy to get time off.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
67% of people report it’s easy to get time off.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
Do Exactech managers change schedules at the last minute?
Most managers don’t change people’s schedules at the last minute.
100% of people say their manager doesn’t change their shift schedule at the last minute.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and August 2025.
100% of people say their manager doesn’t change their shift schedule at the last minute.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and August 2025.
Do jobs at Exactech spill into time workers aren’t paid for?
Rarely. The job doesn't usually spill into unpaid time.
20% of people report that their job takes up time that they don’t get paid for.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and August 2025.
20% of people report that their job takes up time that they don’t get paid for.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and August 2025.
How easy is it to take sick days at Exactech?
Some people find it hard to take sick days.
67% of people report that it’s hard to take time off if they are sick.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
67% of people report that it’s hard to take time off if they are sick.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
Do people at Exactech feel treated with respect by their managers?
Some people don’t feel treated with respect by their managers.
60% of people say they’re not treated with respect by their managers.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and March 2026.
60% of people say they’re not treated with respect by their managers.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and March 2026.
Is it stressful to work at Exactech?
Some people feel stressed here.
67% of people say they often feel stressed at work.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
67% of people say they often feel stressed at work.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
Do people at Exactech enjoy their jobs?
Only some people enjoy their job.
50% of people report they don’t enjoy their job.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
50% of people report they don’t enjoy their job.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
Do people at Exactech recommend working with their team?
Only some people recommend working with their team.
67% of people report that they wouldn’t recommend working with their immediate team to a friend.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
67% of people report that they wouldn’t recommend working with their immediate team to a friend.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
Do people get enough training when they start at Exactech?
Some people didn’t get enough training when they started.
67% of people report they didn’t get enough training when they started working here.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
67% of people report they didn’t get enough training when they started working here.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
Do people get support to advance at Exactech?
Only some people are given support to advance their career here.
In the last year, 50% of people report not being given support to advance their career here.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
In the last year, 50% of people report not being given support to advance their career here.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
Do people think Exactech’s headquarters understands what’s happening where they work?
Most people think headquarters doesn’t understand what’s happening where they work.
100% of people think that this employer’s headquarters or owners don’t have a good understanding of what’s really happening where they work.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and August 2025.
100% of people think that this employer’s headquarters or owners don’t have a good understanding of what’s really happening where they work.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and August 2025.
Do workers feel well informed about how Exactech is doing?
Most people don’t feel well informed about how the company is doing.
80% of people feel that they aren’t kept well informed about how the company is doing as a whole.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and March 2026.
80% of people feel that they aren’t kept well informed about how the company is doing as a whole.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and March 2026.
What other companies are hiring for Regulatory Affairs Manager jobs?
What are the most popular jobs at Exactech?
Exactech rating
8.0
Based on 6 frontline employees who took The Breakroom Quiz
Job description
The Sr Manager, Regulatory Affairs provides strategic leadership for and oversight of the Lifecycle (Postmarket) Regulatory team accountable for Advita's postmarket regulatory affairs, i.e., regulatory support of commercialized products. Accountabilities include activities such as assessment of proposed changes for regulatory impact, regulatory strategy and support for change projects, compliance with Conditions of Approval, EU renewals and regulatory review & approval of advertising and promotion. The Sr Manager, Regulatory Affairs will partner with the business (e.g., BUs, Operations, etc.) and regulatory colleagues (e.g., the BU, Regional and RO & RCoE RA teams) to develop and execute global regulatory strategies in support of commercialized products.
- Oversee the regulatory professionals who manage Advita's Lifecycle (postmarket) RA: recruit, hire, train, develop and direct the work activity of LC RA personnel
- Communicate directly (also through LC RA team members) with regulatory agencies and health authorities regarding registrations, submissions and regulatory strategies
- In partnership with the business and regulatory colleagues (e.g., BU, Operations, and the BU, Regional and RO & RCoE RA teams) develop and execute regulatory strategies and timelines to support proposed changes to commercialized product. Identify and communicate regulatory impact, regulatory requirements and submission deliverables, and execute to achieve regulatory milestones.
- Provide input to the change teams on project and test plans, ensuring that the plans address all elements of the project regulatory strategy
- Maintain awareness of the global regulatory environment; assess and communicate the impact of key environmental changes LC RA initiatives and strategies
- Collaborate with trade associations and regulators to help shape the regulatory environment
- Oversee the regulatory review and approval of post-launch advertising and promotion (A&P); implement and maintain processes to ensure robust and timely pre-release review of A&P
- Oversee compliance with any regulatory Conditions of Approval; implement and maintain systems and/or processes to ensure conditions are met on time
- Support regulatory audits and inspections Interpret and apply medical device regulations and standards
Education:
- A minimum of a Bachelor's Degree from an accredited institution, preferably in physical or life sciences; Master's Degree preferred
Experience:
- Minimum 10 years' experience in medical device industry in regulatory affairs or related field, orthopaedic device industry experience preferred.
- Experience in US, EU and/or international submissions/registrations required
- Working knowledge of US, EU and international medical device regulations required
- Demonstrated experience leading in-depth technical and strategic discussions with Health Authorities required
- Demonstrated ability to influence and negotiate with cross-functional partners and stakeholders, both internal and external required
- Prior team leadership required
- Regulatory Affairs Certification (RAC) preferred
Functional/Technical Knowledge, Skills and Abilities Required:
- Proficiency with windows-based office productivity tools (Microsoft Office)