Job Description:

JOB SUMMARY:

The Regulatory Affairs Specialist is responsible for planning, preparing, coordinating, and managing global regulatory submissions and registrations for medical devices, including US 510(k), EU technical documentation, and international dossiers. The role represents Regulatory Affairs on cross-functional project teams, provides regulatory strategy, assesses the impact of design and manufacturing changes, and ensures compliance across global markets. Key activities include compiling submission packages, interacting with regulatory authorities, supporting audits, reviewing marketing materials, monitoring regulatory developments, and maintaining SOPs to ensure ongoing compliance and effective regulatory operations.

PRIMARY DUTIES & RESPONSIBILITIES:

• Independently plan, prepare, coordinate, track, follow-up, and obtain clearances for medical device submissions including US 510(k), Health Canada licenses, EU technical files, Brazil, Russia, India, China, Japan, and other countries.
• Represent Regulatory Affairs on assigned project teams through all phases of product development, provide Regulatory Strategy and assess regulatory impact of changes on existing products
• Coordinate and prepare document packages for regulatory submissions to the US, EU, and Canada [510(k) Pre-Market Notifications, Product Reports/Supplements, CE Mark, Health Canada].
• Responsible in the preparation and compilation of domestic and international product registration submissions.  This includes, but is not limited to Pre-Market Notifications, 510ks, CE technical files and international dossiers (such as Canada, China, Brazil, Australia, Japan Russia, India, etc.).
• Represent Regulatory Affairs on change controls and provide regulatory assessment.
• Review and approve marketing communication materials
• Provide guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex II and Annex VII and ISO 13485, Canadian CMDCAS, etc.
• Monitor regulatory and legislative environment and provide impact assessment
• Provide information and materials for Certificate to Foreign Governments (CFG), and medical device listings for FDA.
• Support external audits (FDA, notified Body, international regulators, etc.) as requested
• Participate, as assigned, as a CAPA owner, team member, or “task” owner.
• Work with project teams and responsible leaders to provide compliance/product registration requirements and potential effects for design changes and manufacturing process changes. 
• Direct communication with regulatory authorities regarding company’s regulatory filings.
• Remain current on developments in field(s) of expertise, regulatory requirements and industry trends.
• Create and update departmental standard operating procedures (SOPs).

Job Requirements:

• Bachelor's Degree (BA/BS) in Engineering, Life Sciences, or health care-related discipline required.
• 3 years of experience in Medical devices regulatory submissions required.
• 3 years’ experience with successful preparation and submission of 510(k) and international documents and registration and marketing of medical devices worldwide required.

PREFERRED QUALIFICATIONS:

• Experience with FDA, Health Canada and international regulators is strongly preferred.
• Advanced degree and/or Regulatory Affairs Certification (RAC) preferred.
• Ability to clearly communicate and write reports and business correspondence in English.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and other key members in the company while maintaining a high level of professionalism.
• Experience in supporting international registrations.
• Knowledge of US and international medical devices regulations, guidelines, and policies.
• Expert at compiling medical device documents into clear, easy-to-understand submissions packages.
• Expert at writing, reviewing and editing technical documents.
• Highly effective at working with cross-functional teams from diverse disciplines and culture.
• Must be able to negotiate internally and externally with regulatory agencies.
• Identify, communicate and solve regulatory issues with project reams and management.
• Strong organizational skills.
• Ability to read, understand and retain extensive working knowledge of procedures and company documents.
• Excellent MS-Office Applications. 
• Knowledge of computer files management software (QCBD preferred)
• Able to produce positive results with a strong sense of urgency and ability to multi-task.
• Strong interpersonal and presentation skills.
• Knowledge of Quality System Requirements and Standards.

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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.

Operating Company:

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.