Regulatory Specialist Visa Sponsorship Jobs in Massachusetts
Regulatory specialist visa sponsorship jobs in Massachusetts are concentrated in Greater Boston's life sciences corridor, with major employers including Biogen, Bristol Myers Squibb, and Takeda hiring across Cambridge, Waltham, and Lexington. The FDA's New England district presence and Massachusetts's dense biotech cluster make this one of the most active states for sponsored regulatory roles in the country.
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Get Access To All JobsAbout Elevaris Medical Devices
Tired of working at a "good" job?
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
Minimum Requirements:
- 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)
About Elevaris Medical Devices
Tired of working at a "good" job?
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
Minimum Requirements:
- 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)
Regulatory Specialist Job Roles in Massachusetts
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Search Regulatory Specialist Jobs in MassachusettsRegulatory Specialist Jobs in Massachusetts: Frequently Asked Questions
Which companies sponsor visas for regulatory specialists in Massachusetts?
Life sciences and biotech firms are the most active sponsors of regulatory specialists in Massachusetts. Companies like Biogen, Takeda, Bristol Myers Squibb, Vertex Pharmaceuticals, Sanofi, and Moderna have consistent H-1B visa filing histories for regulatory affairs, regulatory submissions, and regulatory compliance roles. Medical device companies such as Boston Scientific also sponsor for regulatory specialists, particularly those with FDA submission experience.
Which visa types realistically fit regulatory specialist roles in Massachusetts?
Regulatory specialist roles typically qualify as specialty occupations requiring a directly related bachelor's degree, making H-1B the most common path. H-1B1 visa is available to Chilean and Singaporean nationals. E-3 visa applies to Australian nationals. For green card pathways, EB-2 suits candidates with advanced degrees, while EB-3 covers those with at least two years of relevant experience. F-1 students may use OPT to work in regulatory roles while transitioning to employer-sponsored status.
Which cities in Massachusetts have the most regulatory specialist sponsorship jobs?
Cambridge and Boston together account for the largest concentration of sponsored regulatory specialist positions, anchored by the Kendall Square biotech hub. Waltham and Lexington host major pharmaceutical company campuses with dedicated regulatory affairs teams. Worcester has a growing medical device presence, and Andover is home to offices for companies such as Takeda. Most sponsored roles cluster along the Route 128 and I-495 corridors west and north of Boston.
How to find regulatory specialist visa sponsorship jobs in Massachusetts?
Migrate Mate lists Massachusetts employers with verified visa sponsorship history for regulatory specialist roles, so you can focus your search on companies that have actively filed for similar positions. Because the Boston area's life sciences market moves quickly, filtering specifically for regulatory affairs, regulatory submissions, and regulatory compliance titles within Massachusetts will surface the most relevant opportunities. Migrate Mate's database reflects actual DOL filing activity rather than self-reported employer claims.
Are there state-specific factors that affect visa sponsorship for regulatory specialists in Massachusetts?
Massachusetts's density of FDA-regulated industries creates unusually high demand for regulatory specialists with drug, biologics, or medical device submission experience. The state's university pipeline, including programs at Northeastern, UMass, and Tufts, produces candidates who start on OPT before transitioning to H-1B sponsorship. Many Massachusetts employers also sponsor regulatory specialists through the EB-2 green card route when roles require advanced scientific or regulatory credentials, reflecting the seniority of positions available here.
What is the prevailing wage for sponsored regulatory specialist jobs in Massachusetts?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.