Principal Regulatory Affairs Specialist

Elevaris Medical Devices; Wilmington (MA); Vor Ort; USD 123.000 - 150.000; Vollzeit

Zusammenfassung

Elevaris Medical Devices seeks a Principal Regulatory Affairs Specialist to lead global regulatory strategies, drive complex submissions, and ensure lifecycle management for precision medical devices. You will partner with cross-functional teams across development, manufacturing, and quality to align regulatory objectives with business priorities.

Ideal candidates bring 8+ years in medical device regulation, extensive FDA submission experience (510(k), PMAs), and deep knowledge of FDA/EU MDR/ISO

Qualifikationen

• Bachelor’s degree in a scientific discipline required; advanced degree preferred.
• 8+ years of progressive Regulatory Affairs experience in medical devices.
• Experience leading FDA submissions including 510(k)s.
• Advanced knowledge of FDA, EU MDR, ISO 13485, and global regulatory requirements.
• Strong project leadership, communication, and risk assessment skills.

Aufgaben

• Develop and lead regulatory strategies supporting new product development, product modifications, market expansion, and lifecycle management.
• Serve as the primary regulatory affairs representative on cross-functional product development teams.
• Provide regulatory guidance and risk assessments related to design, manufacturing, supplier, and labeling changes.
• Lead preparation and submission of 510(k)s, PMAs, IDEs, international registrations, renewals, and regulatory assessments.
• Coordinate responses to regulatory agency requests and represent regulatory perspectives with FDA, Notified Bodies, and global authorities.
• Review and approve engineering changes, labeling, IFUs, promotional materials, and development documentation.
• Develop and maintain Technical Files, Design History Files, and regulatory dossiers.
• Monitor emerging regulations and assess business impact.
• Provide technical mentorship and leadership to Regulatory Affairs team members.

Kenntnisse

Regulatory leadership

FDA submissions

Regulatory strategy

Risk assessment

Cross-functional collaboration

Project management

Global regulatory compliance

Ausbildung

Bachelor’s degree in a scientific discipline

Advanced degree preferred

RAC certification (preferred)

Tools

FDA regulatory knowledge

Jobbeschreibung

At Elevaris, our goal is not to be good, it's to be extraordinary.

Extraordinary performance comes from extraordinary people. And the foundation for extraordinary people is extraordinary culture. Our values describe the behaviors that define our unique culture. They are what set us apart and what makes us trusted leaders in our field.

Elevaris Medical Devices is leveraging a legacy of trust and expertise to usher in a new era of precision medical device development and manufacturing capabilities. We are development and engineering experts focused on delivering precision solutions to our medical device customers. Elevaris Medical Devices is one of the world's leading manufacturers of made-to-spec procedural needles. Beyond needles, we are also a Contract Development and Manufacturing Organization (CDMO) to industry-leading, multi-national healthcare companies, global original equipment manufacturers (OEMs), and emerging technology companies. We also distribute a wide range of complementary pharmaceutical products, surgical instruments, and medical supplies.

Please note this position is onsite in Wilmington Mass.

ROLE PURPOSE

• The Principal Regulatory Affairs Specialist serves as the highest-level individual contributor within Regulatory Affairs and is responsible for developing and executing global regulatory strategies that support product development, registration, commercialization, market expansion, and lifecycle management of Elevaris products. This role provides advanced regulatory leadership for complex projects, serves as a key subject matter expert on U.S., EU, and international regulatory requirements, and partners closely with cross-functional teams to ensure regulatory objectives align with business priorities.
• The position independently leads complex submissions, drives regulatory strategy, assesses regulatory risk, supports agency interactions, and mentors Regulatory Affairs team members while ensuring ongoing compliance with applicable global regulations.

KEY RESPONSIBILITIES & ACCOUNTABILITIES

• Develop and lead regulatory strategies supporting new product development, product modifications, market expansion, and lifecycle management
• Serve as the primary regulatory affairs representative on cross-functional product development teams.
• Provide regulatory guidance and risk assessments related to design, manufacturing, supplier, and labeling changes
• Lead preparation and submission of 510(k)s, PMAs, IDEs, international registrations, renewals, and regulatory assessments
• Coordinate responses to regulatory agency requests and represent regulatory perspectives with FDA, Notified Bodies, and global authorities
• Review and approve engineering changes, labeling, IFUs, promotional materials, and development documentation
• Develop and maintain Technical Files, Design History Files, and regulatory dossiers
• Monitor emerging regulations and assess business impact
• Provide technical mentorship and leadership to Regulatory Affairs team members

DECISION RIGHTS & KEY RELATIONSHIPS

• Independently make regulatory decisions within established frameworks
• Recommend regulatory strategies and risk mitigation approaches for complex projects
• Collaborate with Quality, R&D, Clinical Affairs, Manufacturing, Supply Chain, Marketing, and Commercial teams

WHAT SUCCESS LOOKS LIKE

• Regulatory submissions are completed accurately and on schedule
• Products remain compliant with global regulations
• Regulatory risks are proactively identified and mitigated
• Regulatory strategies support business growth and innovation

CAPABILITIES & QUALIFICATIONS

• Bachelor’s degree in a scientific discipline required; advanced degree preferred
• 8+ years of progressive Regulatory Affairs experience in medical devices
• Experience leading FDA submissions including 510(k)s
• Advanced knowledge of FDA, EU MDR, ISO 13485, and global regulatory requirements
• Strong project leadership, communication, and risk assessment skills

Preferred Qualifications:

• RAC certification

HOW WE WORK

At Elevaris, what we accomplish matters — and so does how we accomplish it. Every employee is expected to demonstrate our Values of Integrity, Invested, Inclusion and Ingenuity through their everyday decisions, behaviors and interactions.

WORK ENVIRONMENT & PHYSICAL REQUIREMENTS

The physical demands described here are representative of those required to successfully perform the essential functions of this role. Reasonable accommodation may be made in accordance with applicable local laws. Contact your manager or HR to understand the work conditions and physical requirements that may be specific to your role.

• 10-15% domestic and international travel as required
• Regular use of computer and communication tools
• Ability to work independently and/or in a team environment
• Additional requirements may vary by role and location

GLOBAL COMPLIANCE & EQUAL OPPORTUNITY

Elevaris is committed to providing equal employment opportunities in all locations where we operate. We do not discriminate on the basis of any characteristic protected by applicable local laws.

An Equal Opportunity Employer/Contractor: Elevaris believes that all persons are entitled to equal employment opportunity. The Company will not discriminate or tolerate discrimination against any employee or applicant because of race, color, creed, religion, genetic information, sex, sexual orientation, national origin, age, status with regard to public assistance, marital or veteran status, disability or any other characteristic protected by local, state or federal law. Equal employment opportunity will be extended to all persons in all aspects of the employer-employee relationship, including recruitment, hiring, training, promotion, transfer, discipline, layoff, recall and termination. Disabled applicants may request any reasonable accommodation needed to enable them to complete the application process.

The pay range for this role is:

123,000 - 150,000 USD per year (Wilmington MA)