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).
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.
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: https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf
