Getinge Group Looking for Regulatory Affairs Specialist II at Wayne, NJ Full Time

At Getinge we have the passion to perform

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers – and to save more lives.

Are you looking for an inspiring career? You just found it.

Job Responsibilities and Essential Duties

• Maintain list of external standards as required for the Merrimack site.
• Lead and Coordinate monthly Standard Adoption and Assessment meetings.
• Ensure appropriate subject matter expert/functional owner is assigned to each required Standard Assessment.
• Maintain relevant tracking documentation with the status of each Standard Assessment, ensures timely completion of assessments, and performs escalation as required.
• Review submitted Standard Assessment documentation for accuracy, typographical errors, and completeness.
• Identify relevant new and revised standards and regulations and obtain electronic versions for addition to the appropriate library.
• Perform standard assessments.
• Obtains electronic versions of standards requested by the Merrimack site and ensure costs are processed applicably.
• Maintain all necessary Board of Pharmacy state licenses (across the USA) by working with contractors and state agencies to obtain and renew manufacturer and wholesaler licenses.  
• Participate in CAPA activities as a team member or team lead.
• Act as point person for field correction and recall activities at the Merrimack site.
• Assist in the preparation of documentation and activities related to Regulatory submission including EuMDR, PMA, 510(k), IDE submissions and international registrations.
• Communicate directly with FDA, Notified body,  and International Ministries of Health and governing bodies.
• Support internal and external audit activities.

Assists in special projects as needed.

Minimum Requirements

• Bachelors degree in Science, or equivalent is preferred.
• Experience with Quality Standards

Required Knowledge, Skills and Abilities

• Good working knowledge of MS Office (Word, Excel, Outlook).
• Ability to communicate effectively across departments.
• Project management and leadership experience is preferred.

Internal and External Contacts/Relationships

• Maintains effective relationships with internal customers.
• Build relationships and participates as a member of the Regulatory team.

Quality Requirements

• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
• Attend all required Quality & Compliance training at the specified interval.
• Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
• Duties are performed in an office environment. May work extended hours during peak business cycles.
• Physical requirements such as lifting a specified weight on a regular basis, standing for a period of time.
• Some traveling may be required.

About us 

Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. Our passionate people hold our brand promise ‘Passion for Life’ close to heart. 

If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world’s most respected and trusted MedTec company.

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.