Job Description:

JOB SUMMARY:

The Regulatory Affairs Specialist is responsible for assembling CE Technical files and final review of deliverables for MDR regulatory compliance. Also tracks marketing clearances/approvals, licenses, and applications for products to support sustainment projects and new product launches.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Represents the RA function on core teams. Provides RA guidance/opinions for team questions.
• Responsible for developing and executing regulatory strategies for sustaining and new products.
• Independently prepare and maintain EU MDR technical files, Australian and New Zealand registrations.
• Maintain accurate FDA device listing.
• Create action plans to ensure milestones and due dates are met.
• Evaluates New Product Development and sustaining engineering change requests (ECR/ECOs).
• Conduct regulatory assessments for new product development and sustaining activities.
• Review Nonconformance Reports for regulatory impact under supervision.
• Support CAPA projects.
• Responsible for regulatory review of product claims and marketing materials/social media/websites.
• Organize and maintain files/folders/databases to support the integrity of RA documentation.
• Review and redline product labels/IFUs to meet global regulatory requirements.
• Ensure label conformity to global UDI requirements and submit/maintain UDI databases under supervision.
• Develop and generate departmental SOPs.
• Participates in audits and inspections of the company and its Quality Systems. 
• Prepares monthly reports on status of current issues to the Manager of Regulatory Affairs.
• Work on ad-hoc projects when required.
• Request Certificate of Foreign Government and Certificates of Free Sale.
• Resolve regulatory issues and ensure companywide compliance.
• Review regulatory publications to keep apprised of new regulatory developments.
• Perform special projects at the direction of the Regulatory Affairs Management.

Job Requirements:

• Bachelor’s degree from a four-year college or university in a related field plus 2 years of relevant regulatory affairs experience required OR

• High school diploma or equivalent AND 4 years of relevant regulatory affairs work experience required, preferably in the Medical Device or Pharmaceutical industry or technical field.

• Ability to understand technical product information.

PREFERRED SKILLS:

• Advanced degree or RAC certification preferred.

• Experience with Domestic submissions:  US & Canada

  Demonstrated international submissions experience (i.e., Saudia Arabia, APAC, LATAM, EU, Health Canada Technical files a plus).

  EU MDR/MDD or international submissions highly preferred.

• Effective collaborator with department and cross-functional team members and comfortable working independently with limited direction/supervision.

• RA Project exposure working with cross functional teams.

• Demonstrated organizational problem-solving skills, project coordination skills and computer literacy in Microsoft Office suite, databases and electronic document management systems.

• Enthusiastic self-starter with excellent verbal, written, and interpersonal skills.

• Highly organized, detail-oriented “mindset” and ability to be flexible and multi-task in a dynamically changing environment.

• The ability to interpret and provide guidance on regulations from various countries.

• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.

• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.

• Ability to write routine reports and correspondence. 

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Target Market Salary Range:

Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled.  At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.

$65,600 - $98,300

Operating Company:

Kerr

Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate.  Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes.  An Agency must obtain advance written approval from Envista’s internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.  Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.