Sr Regulatory Affairs Specialist

Job ID
2021-2729
Category
Quality Assurance & Regulatory Affairs
Location : City
Madison

Job Description

Promega is an international bio-tech company with over 4000 high quality products that have been supporting science for over 40 years. We support scientists researching life and disease, pharma companies developing new treatments, forensic labs matching DNA from crime scenes and clinical labs running and confirming health tests - and that’s just the beginning. And yes, we have been extremely busy providing our technologies to support COVID-19 testing and research.


We strive to create an open, inviting and inclusive culture – we care about you as a person, not just a team member. We embrace the principles of emotional and social intelligence – which helps our employees improve relationships, manage stress and enhance connections. Establishing and maintaining relationships is part of the foundation of our culture - teams are more like family than co-workers.


Our campus speaks volumes. Headquartered in Madison, employees work in and around a campus with multiple buildings that are integrated into a natural setting with trails, ponds, woods and a restored prairie. Sustainability is important – we invest in energy efficiency and use renewable energy. Our culinary team offers top notch food to employees – including an onsite garden to supply fresh produce. Check out our campus through this map, and learn more about the our people and sustainable practices.

 

OUR TEAM: We are a small team of very motivated and energetic individuals. We are always seeking to drive speed to market by the least burdensome, but compliant path.  We work very closely together on new product development and realization projects and ensure that we support each other in our day-to-day roles and in our department.

 

YOUR ROLE: As part of our Regulatory Affairs team, you will be an important part of our new product development and realization teams from start to finish making sure all regulatory requirements are met. You will apply your strategic thinking and creativity skills to help support our programs, and we will also look to you to help mentor and train others on regulatory topics. You don’t live in the Madison area? This position can be virtual, onsite, or a combination of both!

YOUR EXPERIENCE: You will bring at least 8-10 years regulatory affairs experience including experience with in vitro diagnostics devices and will share your experience with 510(k)s, pre-market approvals, and CE marking as well. You are a self-starter with excellent communication skills and are comfortable working with all levels of the organization.

 

JOB OBJECTIVE: Provide regulatory support to ensure that Promega products comply with relevant domestic and international medical device and electrical equipment regulations. Provide regulatory guidance to cross-functional partners and demonstrate strategic thinking and creativity in support of programs. Lead the preparation and submission for regulatory approvals and act independently to identify and resolve problems. Develop and maintain required documentation to support regulated products.

 

PRIMARY FUNCTIONS:

1. Prepares robust regulatory applications to achieve departmental and organizational objectives

2. Creates, reviews and approves change records

3. Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team

4. Provides guidance and expertise

5. Acts as liaison between the Company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail

6. Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems

7. Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations. Interfaces directly with FDA and other regulatory agencies

8. Conducts reviews of product and manufacturing changes for compliance with applicable regulations. Reviews protocols and reports to support regulatory submissions


CORE DUTIES:

1. Evaluate regulatory impact of proposed products.

2. Understand, investigate and evaluate regulatory requirements.

3. Provide regulatory guidance and assess regulatory implications for Promega products throughout the product lifecycle.

4. Prepare regulatory applications, registrations, and submissions to authorities, e.g. FDA.

5. Maintain documentation needed to support regulated product throughout the product’s lifecycle.

6. Review and approval of product labeling (label disclaimers).

7. Review and approval of product literature as well as advertising and promotional materials for compliance to applicable regulations.

8. Facilitate risk assessments for regulated products.

9. Evaluate risks based on regulatory factors; provide options and recommendations to mitigate risk.

10. Understand and comply with ethical, legal and regulatory requirements applicable to our business.

OCCASIONAL DUTIES:

1. Organize, facilitate, or lead meetings to discuss review findings and planning issues.

2. Provide regulatory support for Promega branches.

3. Develop and conduct regulatory training, as needed.

4. Ability to develop concise, clear communication and presentations that contain both analysis and possible solutions. Experience in writing procedures and reviewing documents required to support regulated products.

5. Provide regulatory input for complaint investigations and product recalls.

KEY QUALIFICATIONS:

1. BS degree; technical discipline preferred. Bachelor’s degree in life science, chemistry, or biochemical field.

2. Minimum of 8 – 10 years experience in the medical devices or in vitro diagnostic devices industry, including at least 4 years of regulatory affairs experience.

3. Comprehensive knowledge of applicable FDA regulations and experience with EU Directives and other international medical device regulations and submissions.

4. Experience with 510(k) applications, PMA supplements and US device regulations.

5. Proficiency in MS Word, Excel and other standard software programs.

6. Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization and with work constructively with a broad range of people, both internally and externally, to achieve results.

7. Experience working in a broad cross-organizational business model preferred.

PREFERRED QUALIFICATIONS:

1. Regulatory Affairs Certified (RAC) certification.

2. Experience in developing EU Technical Files to support regulated product.

3. Experience in developing compliance files or submissions to support regulated product in other markets.

4. Ability to travel up to 10%.

PHYSICAL REQUIREMENTS:

1. Ability to wear basic safety apparel (safety glasses or goggles, lab coats, and protective gloves).

2. Ability to use computers in an interactive manner for extended periods of time.

3. Ability to travel up to 10% of the time.

 

 


Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.

 

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