Regulatory Affairs Specialist

Job ID
2021-2728
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 requirments are met.  You will work to communicate and ensure that our products comply with regulations and provide top-notch regulatory support.  You don't live in Madison area? This position can be virtual, onsite, or a combination of both!

 

YOUR EXPERIENCE: You will bring at least 2-4 years regulatory affairs experience including experience with in vitro diagnostics devices and will share your experiences with 510(k)s, pre-market approvals, and CE marking as well.  You are a self-starter with excellent communication skills and have a knack for detail.

 

JOB OBJECTIVE: Provide regulatory support to different areas of the company to ensure that Promega products comply with relevant domestic and international medical device and electrical equipment regulations. Develop and maintain required documentation to support regulated products. Prepare submissions to regulatory authorities when needed.

 

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, product registrations and submissions (510(k), PMA) to FDA and other global regulatory bodies.

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

6. Review and approval of product labeling.

7. Review and approval of product literature for compliance to applicable regulations.

8. Review and approve advertising and promotional literature to ensure compliance to intended use.

9. Facilitate risk assessments for regulated products.

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

11. Supporting Regulatory Affairs domestically as well as European registrations and submissions, technical file maintenance, recall coordination and medical device reporting.

12. Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers.

13. Support company registrations and device listings in the US, Canada, EU, China, and others as needed.

14. Support creation and maintenance of technical files and Declarations of Conformity in support of EU product registrations/CE mark.

15. Support for all product Field Actions.

16. Supports internal/external audits and regulatory inspections.

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


KEY QUALIFICATIONS:

1. Bachelor's Degree (B.S.) from a four-year college or university in Engineering, Bio-Medical Engineering, Sciences or related field.

2. Minimum of 2 - 4 years of Regulatory Affairs work experience in medical device (Class II).

3. Strong knowledge and experience with 510(k) preparations and submissions required.

4. Current knowledge of FDA and International quality system regulations required.

5. Experience following Device Design Controls and Risk Management Processes.

6. Experience with IVDs, Electronic Medical Equipment is a plus.

7. Must be able to work with minimal direction. Strong attention to detail and sound ability to interpret, translate and address regulatory needs.

8. Experience in various software and database applications to enhance individual productivity.

9. Strong oral and written communication skills. Demonstrated ability to read, understand and assist others in developing means to comply with regulations while meeting business needs.

PREFERRED QUALIFICATIONS:

1. Bachelor’s Degree preferably in a scientific, engineering, regulatory, internal audit, pre-medical, legal, or general business core concentration.

2. 4 – 6 years of combined Regulatory and Quality experience.

3. Experience with Canada, EU and other international countries submissions.

4. MDR and Vigilance reporting, eMDR and UDI experience.

5. Regulatory Affairs Certified (RAC) certification.

6. Experience working within a quality system such as ISO 9001, ISO 13485, FDA cGMP.

7. Experience with the FDA Guidance document for RUO/IUO products.

PHYSICAL REQUIREMENTS:

1. Ability to work with computer equipment.

2. Ability to move boxes weighing up to 30 lbs.

3. Ability to use PPE as necessary to perform assigned tasks.

 


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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